Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation

Functional Constipation Clinical Trial

Official title:

Dose-ranging Efficacy of Supplementation With Polydextrose, a Dietary Fibre, on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314936
• Other study ID #: 01-2014
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2018
• Source: KGK Science Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effectiveness of Polydextrose, a dietary fiber, at decreasing Colonic Transit Time and the gastrointestinal symptoms of Functional Constipation. One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive 8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter will receive a placebo daily.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 70 years.

2. Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight).

3. If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).

OR

Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:

Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Double barrier method, Vasectomy of partner (shown successful as per appropriate follow-up), Tubal ligation, and Non-heterosexual lifestyle (same sex partner).

4. Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):

Must meet 2 or more of the following criteria:

Straining during at least 25% of defecations, Lumpy or hard stools in at least 25% of defecations, Sensation of incomplete evacuation for at least 25% of defecations, Sensation of anorectal obstruction/blockage for at least 25% of defecations, Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)

Fewer than three defecations per week

Loose stools are rarely present without the use of laxatives

Insufficient criteria for irritable bowel syndrome

5. Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.

6. Consent to the study and willing to comply with study product and methods.

7. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Exclusion Criteria:

1. Major gastrointestinal complication (e.g. Crohn's disease, colitis, celiac disease)

2. Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results.

3. Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness).

4. Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products.

5. Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study).

6. Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs), within 1 month before screening.

7. Anticipated major dietary or exercise changes during the study.

8. Systemic steroid use, within 1 month before screening.

9. Eating disorder.

10. Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product).

11. History of alcohol, drug, or medication abuse.

12. Pregnant or lactating female, or pregnancy planned during study period.

13. Participation in another study with any investigational product within 60 days of screening.

14. Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.

15. Subject under administrative or legal supervision.

16. Subject who would receive more than 4500 Euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Dietary Supplement:
• Litesse powder containing 12 g polydextrose
12 g polydextrose
• Litesse powder containing 8 g polydextrose
8 g polydextrose, 4 g maltodextrin
• Litesse powder containing 4 g polydextrose
4 g polydextrose, 8 g maltodextrin
• Placebo
12 g Maltodextrin

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Science Inc.	DuPont Nutrition and Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Hemoglobin Levels From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically hemoglobin in this outcome).	Screening and Day 15 (end of study)
Other	Change in Hematocrit Levels From Screening to Day 15	Safety will be evaluated by measuring the change in whole blood hematology (specifically hematocrit levels in this outcome).	Screening and Day 15 (end of study)
Other	Change in White Blood Cell Count From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically white blood cell count in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Red Blood Cell Count From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically red blood cell count in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Mean Corpuscular Volume From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular volume in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Mean Corpuscular Hemoglobin From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Red Cell Distribution Width From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically red cell distribution width in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Platelet Count From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically platelet count in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Neutrophil Count From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically neutrophil count in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Lymphocyte Count From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically lymphocyte count in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Monocyte Count From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically monocyte count in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Eosinophil Count From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically eosinophil count in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Basophil Count From Baseline to Day 15	Safety will be evaluated by measuring whole blood hematology (specifically basophil count in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Glucose Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically glucose concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Creatinine Levels in Blood From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically creatinine concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Urea Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically urea concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically estimated glomerular filtration rate in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Sodium Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically sodium concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Potassium Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically potassium concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Chloride Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically chloride concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Calcium Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically calcium concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Carbon Dioxide Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically carbon dioxide concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Phosphate Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically phosphate concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Bilirubin Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically bilirubin concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically aspartate transaminase concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Alanine Transaminase Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically alanine transaminase concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically alkaline phosphate concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically gamma-glutamyltransferase concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Serum C-Reactive Protein Concentration From Baseline to Day 15	Safety will be evaluated by measuring blood serum variables (specifically C-reactive protein concentration in this outcome measure).	Screening and Day 15 (end of study)
Other	Change in Specific Gravity Urinalysis Parameter From Screening to Day 15	Safety will be evaluated by measuring urine analyses (specifically specific gravity in this outcome measure). The reference range for specific gravity are 1.001 - 1.030 mmol/L, with no alerting or critical values.	Screening and Day 15 (end of study)
Other	Change in pH Urinalysis Parameter From Baseline to Day 15	Safety will be evaluated by measuring urine analyses (specifically urine pH in this outcome measure). Urine pH reference range is between 5.0 - 8.0, with no alerting or critical values.	Screening and Day 15 (end of study)
Other	Number of Subjects With Adverse Events	Adverse events were recorded in a daily diary during the 14-day run-in period and the 14-day treatment period. All types of adverse events as well as the total number of all adverse events reported were used in this outcome measure.	14 days run-in and 14 days treatment
Primary	Change in Colonic Transit Time From Baseline to Day 15	Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.	Baseline and Day 15
Secondary	Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15	Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score).; The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales.; All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score.	Baseline and Day 15
Secondary	Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15	Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score); The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires.; The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items).; A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items.	Baseline and Day 15
Secondary	Change in Bowel Function Index From Baseline to Day 15	Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation).; Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions.	Baseline and Day 15
Secondary	Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15	Assessed using single question dichotomous tool.; Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation.	Baseline and Day 15
Secondary	Change in Stool Frequency From Baseline to Day 15	Participants will record the number of defecations per day in a daily diary	14 day run-in and Week 2 of the 14-day supplementation period
Secondary	Change in Stool Consistency From Baseline to Day 15	Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form.; Bristol Stool Scale: The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5.	14 day run-in and Week 2 of the 14-day supplementation period
Secondary	Change in the Degree of Straining During Defecation From Baseline to Day 15	Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale.; The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining.	14 day run-in and Week 2 of the 14-day supplementation period
Secondary	Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15	Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous "yes" or "no" scale.; The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2.	14 day run-in and Week 2 of the 14-day supplementation period
Secondary	Change in the Severity of Abdominal Discomfort From Baseline to Day 15	Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale.; The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining.	14 day run-in and Week 2 of the 14-day supplementation period
Secondary	Change in the Bloating Severity From Baseline to Day 15	Severity of bloating will be recorded each day in a daily diary on a 5-point scale.; The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining.	14 day run-in and Week 2 of the 14-day supplementation period
Secondary	Overall Product Satisfaction	Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale.; The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement.	Assessed at Day 15 (end of study)