Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time

Functional Constipation Clinical Trial

— PDX-Transit  

Official title:

Dose-ranging Efficacy of 2-week Polydextrose Supplementation on Whole Gut Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebocontrolled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01540669
• Other study ID #: Q-PRE-0111-CLI-007
• Status: Terminated
• Phase: N/A
• First received: February 23, 2012
• Last updated: January 21, 2016
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2016
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to test the effect of polydextrose on whole gut transit time and gastrointestinal symptoms in a dose-responsive manner.

Description:

Given the promising, yet largely unsubstantiated, benefits of fiber supplementation, particularly polydextrose, on symptoms of functional constipation, the objective of this clinical trial is to evaluate the safety and effectiveness of 2-week supplementation of a proprietary polydextrose fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 70 years

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

• 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

• 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

• Consent to the study and willing to comply with study product and methods

• Willingness to maintain a stable diet throughout the study

• Consistent use and dose of chronic medication, if any, in the past 30 days

Exclusion Criteria:

• Major gastrointestinal complication (e.g. Crohn?s disease, colitis, celiac disease)

• Febrile diverticulitis within 1 year of screening

• Pelvic floor dysfunction

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

• Prior abdominal surgery of the following type: gastric bypass, lap band, colectomy, removal of gall bladder

• Clinically significant underlying systemic illness that may preclude the subject?s ability to complete the trial or that may confound the study outcomes

• Any clinically relevant abnormalities in the physical examination or in laboratory variables before entry into the study

• Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening

• Laxative, fiber supplement, or other constipation medication (e.g. prokinetic drugs) use within 2 weeks of screening

• Antibiotic use within 1 month of enrollment

• Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#- antagonists, antacids with magnesium or aluminum, or diarrhea medication)

• Anticipated major dietary or exercise changes during the study period

• Known allergies to any substance in the study product

• Pregnant or lactating female, or pregnancy planned during study period

• Eating disorder

• History of alcohol, drug, or medication abuse

• Participation in another study with any investigational product within 3 months of screening

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Dietary Supplement:
• Polydextrose, low dose
4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
• Polydextrose, medium dose
8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
• Polydextrose, high dose
12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
• Placebo powder
Placebo powder will be mixed with beverage and consumed once per day for 2 weeks

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Danisco	Sprim Advanced Life Sciences

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole gut transit time		2 weeks	No
Secondary	Patient assessment of constipation quality of life		2 weeks	No
Secondary	Patient assessment of constipation symptoms		2 weeks	No
Secondary	Bowel Function Index		2 weeks	No
Secondary	Adequate relief of constipation		2 weeks	No
Secondary	Bowel movement frequency		2 weeks	No
Secondary	Stool consistency		2 weeks	No
Secondary	Degree of straining		2 weeks	No
Secondary	Subjective assessment of bowel emptying		2 weeks	No
Secondary	Abdominal discomfort/bloating		2 weeks	No
Secondary	Overall product satisfaction		2 weeks	No
Secondary	Blood and urine safety analysis		2 weeks	Yes
Secondary	Adverse events		2 weeks	Yes