The Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children

Gastrointestinal Tolerance Clinical Trial

Official title:

A Randomized, Controlled, Crossover Study to Assess the Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213494
• Other study ID #: BIO-2108
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: October 28, 2021

Study information

• Verified date: January 2022
• Source: Tate & Lyle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of PROMITOR® Soluble Corn Fiber versus inulin on GI symptoms (tolerance), stool consistency (laxation) and fecal microbiome at levels that could contribute to closing the fiber gap. The dose response effects of PROMITOR® Soluble Corn Fiber in healthy children will also be compared.

Description:

After initial site visits and randomization children were given a packet of powdered fiber to be mixed into a beverage daily. There were four test arms, described elsewhere. Each study arm lasted 10 days with an 18 day washout in between study periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

Inclusion Criteria:

1. Male or female, 3-9 years of age, inclusive at Visit 1 (Day -7)

2. Potty trained

3. Bowel movement at least every other day.

4. Regularly consumes breakfast (at least 5 times/week) and agrees to consume breakfast every day during each test period.

5. Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial.

6. Willing to refrain from exclusionary medications, supplements, and products throughout the study.

7. No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history.

8. Caregiver understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator and subject provides informed assent.

Exclusion criteria

1. Regular (>2/week) moderate to severe GI symptoms (as reported by subject and/or caregiver at Visit 1, Day -7). Mild and infrequent (= 2/week) GI symptoms are allowed.

2. Subject will be away from caregiver for more than 1 day during the 3-day baseline period (Days -3, -2, and -1) and >48 consecutive hours during the 10 days of study product consumption during each test period. Goal is to recruit subjects who will be with their caregiver all or most of the time to minimize missing data.

3. Clinically important GI conditions that would potentially interfere with the evaluation of the study product [e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, gastroparesis, and clinically significant lactose and gluten intolerance or other food or ingredient allergies which includes allergies to milk, eggs, peanuts, tree nuts, wheat and soy (Appendix 9)].

4. Recent (within 2 weeks of Visit 1; Day -7) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as = 3 loose or liquid stools/day).

5. Caregiver-reported history (within 4 weeks of Visit 1; Day -7) of any constipation (<3 bowel movement/week) and diarrhea (=3 of more loose stools/day) at the discretion of the Clinical Investigator.

6. Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic, neurological (e.g., depression and/or anxiety disorders) or biliary disorders. Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.

7. Uncontrolled hypertension determined by the blood pressure measured at Visit 1 (Day -7) and defined as (https://www.emedicinehealth.com/pediatric_vital_signs/article_em.htm):

• Children 3-5 years old: Systolic blood pressure >107 mm Hg and diastolic blood pressure >71 mm Hg

• Children 6-9 years old: Systolic blood pressure >110 mm Hg and diastolic blood pressure >73 mm Hg One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects whose blood pressure exceeds either of these cut points at Visit 1 (Day -7), in the judgment of the Clinical Investigator.

8. Extreme dietary habits as determined using the Diet Questionnaire (Appendix 2) and at the discretion of the Clinical Investigator.

9. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.

10. Major trauma or any other surgical event within 3 months of Visit 1 (Day -7).

11. Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1 (Day -7). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1 (Day -7).*

12. Weight loss or gain >4.5 kg in the 3 months prior to Visit 1 (Day -7).

13. Currently or planning to be on a weight loss regimen during the study.

14. Antibiotic use within 3 months of Visit 1 (Day -7).

15. Use of steroids within 1 month of Visit 1 (Day -7).

16. Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDs) within 1 month of Visit 1 (Day -7).

17. Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to prebiotics or probiotics, laxatives, enemas, fiber supplements and/or suppositories, antacids, anti-diarrheal agents, and/or anti-spasmodic within 2 weeks of Visit 1 (Day -7). Standard multivitamin and mineral supplements are allowed. Clinic staff will check ingredient lists of supplements for presence of prebiotics or probiotics.

18. Use of allergy medications (prescription or over the counter) for >2 times/week within 2 weeks of Visit 1 (Day -7).

19. Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -7).

20. Has a condition the Clinical Investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.

• If an infection occurs during the study period, test visits will be rescheduled until signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to study visits.

5.4.3 Excluded Products

• Antibiotics within 3 months of Visit 1 (Day -7) and throughout the study period.

• Steroids within 1 month of Visit 1 (Day -7) and throughout the study period.

• Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDs) within 1 month of Visit 1 (Day -7) and throughout the study period.

• Medications (over-the-counter or prescription) and/or dietary supplements known to influence GI function, including but not limited to prebiotics or probiotics, laxatives, enemas, fiber supplements and/or suppositories, antacids, anti-diarrheal agents, and/or anti-spasmodic excluded within 2 weeks of Visit 1 (Day -7) and throughout the study period. Standard multivitamin and mineral supplements are allowed.

• Allergy medications of >2 times/week within 2 weeks of Visit 1 (Day -7). Consumption of any of these excluded products during the study period should be documented and subjects may be excluded from the Per Protocol population following a review of protocol deviations at the end of the intervention. Should a subject require any of these excluded products, the study staff should consult with the Clinical Investigator and/or designee to determine future action (e.g., early termination, extension of washout period, etc.)

Related Conditions & MeSH terms

• Gastrointestinal Tolerance

Intervention

Other:
• Inulin
Inulin, a dietary fiber, will be given in a beverage daily in doses 3g, 5g, 6g, or 8g dependent on arm and age of participants.
• soluble corn fiber
soluble corn fiber, a dietary fiber, will be given in a beverage daily in doses 3g, 5g, 6g, or 8g dependent on arm and age of participants.

Locations

Country	Name	City	State
United States	Biofortis Innovation Services	Addison	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Tate & Lyle	Biofortis Innovation Services

Country where clinical trial is conducted

United States, 

References & Publications (13)

Aziz I, Whitehead WE, Palsson OS, Törnblom H, Simrén M. An approach to the diagnosis and management of Rome IV functional disorders of chronic constipation. Expert Rev Gastroenterol Hepatol. 2020 Jan;14(1):39-46. doi: 10.1080/17474124.2020.1708718. Epub 2020 Jan 2. Review. — View Citation

Boler BM, Serao MC, Bauer LL, Staeger MA, Boileau TW, Swanson KS, Fahey GC Jr. Digestive physiological outcomes related to polydextrose and soluble maize fibre consumption by healthy adult men. Br J Nutr. 2011 Dec;106(12):1864-71. doi: 10.1017/S0007114511002388. Epub 2011 May 31. — View Citation

Ho J, Nicolucci AC, Virtanen H, Schick A, Meddings J, Reimer RA, Huang C. Effect of Prebiotic on Microbiota, Intestinal Permeability, and Glycemic Control in Children With Type 1 Diabetes. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4427-4440. doi: 10.1210/jc.2019-00481. — View Citation

Housez B, Cazaubiel M, Vergara C, Bard JM, Adam A, Einerhand A, Samuel P. Evaluation of digestive tolerance of a soluble corn fibre. J Hum Nutr Diet. 2012 Oct;25(5):488-96. doi: 10.1111/j.1365-277X.2012.01252.x. Epub 2012 Jun 6. — View Citation

Karalus M, Clark M, Greaves KA, Thomas W, Vickers Z, Kuyama M, Slavin J. Fermentable fibers do not affect satiety or food intake by women who do not practice restrained eating. J Acad Nutr Diet. 2012 Sep;112(9):1356-1362. doi: 10.1016/j.jand.2012.05.022. Epub 2012 Jul 6. — View Citation

Klosterbuer AS, Hullar MA, Li F, Traylor E, Lampe JW, Thomas W, Slavin JL. Gastrointestinal effects of resistant starch, soluble maize fibre and pullulan in healthy adults. Br J Nutr. 2013 Sep 28;110(6):1068-74. doi: 10.1017/S0007114513000019. Epub 2013 Feb 7. — View Citation

Klurfeld DM, Davis CD, Karp RW, Allen-Vercoe E, Chang EB, Chassaing B, Fahey GC Jr, Hamaker BR, Holscher HD, Lampe JW, Marette A, Martens E, O'Keefe SJ, Rose DJ, Saarela M, Schneeman BO, Slavin JL, Sonnenburg JL, Swanson KS, Wu GD, Lynch CJ. Considerations for best practices in studies of fiber or other dietary components and the intestinal microbiome. Am J Physiol Endocrinol Metab. 2018 Dec 1;315(6):E1087-E1097. doi: 10.1152/ajpendo.00058.2018. Epub 2018 Aug 21. — View Citation

Molly K, Vande Woestyne M, Verstraete W. Development of a 5-step multi-chamber reactor as a simulation of the human intestinal microbial ecosystem. Appl Microbiol Biotechnol. 1993 May;39(2):254-8. — View Citation

So D, Whelan K, Rossi M, Morrison M, Holtmann G, Kelly JT, Shanahan ER, Staudacher HM, Campbell KL. Dietary fiber intervention on gut microbiota composition in healthy adults: a systematic review and meta-analysis. Am J Clin Nutr. 2018 Jun 1;107(6):965-983. doi: 10.1093/ajcn/nqy041. — View Citation

Stewart ML, Nikhanj SD, Timm DA, Thomas W, Slavin JL. Evaluation of the effect of four fibers on laxation, gastrointestinal tolerance and serum markers in healthy humans. Ann Nutr Metab. 2010;56(2):91-8. doi: 10.1159/000275962. Epub 2010 Jan 19. — View Citation

Timm DA, Thomas W, Boileau TW, Williamson-Hughes PS, Slavin JL. Polydextrose and soluble corn fiber increase five-day fecal wet weight in healthy men and women. J Nutr. 2013 Apr;143(4):473-8. doi: 10.3945/jn.112.170118. Epub 2013 Feb 20. — View Citation

Van Hul M, Karnik K, Canene-Adams K, De Souza M, Van den Abbeele P, Marzorati M, Delzenne NM, Everard A, Cani PD. Comparison of the effects of soluble corn fiber and fructooligosaccharides on metabolism, inflammation, and gut microbiome of high-fat diet-fed mice. Am J Physiol Endocrinol Metab. 2020 Oct 1;319(4):E779-E791. doi: 10.1152/ajpendo.00108.2020. Epub 2020 Aug 24. — View Citation

Whisner CM, Martin BR, Nakatsu CH, McCabe GP, McCabe LD, Peacock M, Weaver CM. Soluble maize fibre affects short-term calcium absorption in adolescent boys and girls: a randomised controlled trial using dual stable isotopic tracers. Br J Nutr. 2014 Aug 14;112(3):446-56. doi: 10.1017/S0007114514000981. Epub 2014 May 22. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dose response effects of soluble corn fiber on GI tolerance, stool consistency and bowel habits and fecal microbiome	Caregivers will be asked to help subjects complete an electronic BHD-BSS during the 3 days immediately prior to Visit 2 (Day 0) for collection of baseline information. Caregivers will also be asked to help subjects complete the BHD-BSS every day during the 10 days of study product consumption during each test period. If bowel movement occurs while the subject is not in close proximity to the caregiver (e.g., when subject is at school), the caregivers will be instructed to record the time of the bowel movement as best as possible, but not complete any other details (e.g., straining, consistency, etc) about that particular bowel movement. The diary will provide information on stool frequency and consistency, straining and discomfort during bowel movement, and any sensation of incomplete evacuation. Caregivers will be provided instructions on how to access the electronic BHD-BSS at Visit 1 (Day -7).; Fecal samples will be collected using Omnigene®-GUT DNA Genotek per manufacturer's	up to 10 days
Primary	GI Tolerance Composite Score	The electronic Bedtime GITQ contains a series of questions regarding the presence and severity of GI symptoms occurring from start of study product consumption in the morning until bedtime. The electronic Morning GITQ contains a series of questions regarding the presence and severity of GI symptoms occurring from bedtime until immediately prior to the consumption of study product the next morning. Individual GI symptoms include: gas/flatulence, abdominal cramping, abdominal distention/bloating, borborygmus/stomach rumbling, burping, and nausea and their severity is ranked on a 4-point scale ranging from none to severe.	10 day study period
Secondary	Effects of consuming soluble corn fiber on individual GI symptoms	The electronic Bedtime GITQ contains a series of questions regarding the presence and severity of GI symptoms occurring from start of study product consumption in the morning until bedtime. The electronic Morning GITQ contains a series of questions regarding the presence and severity of GI symptoms occurring from bedtime until immediately prior to the consumption of study product the next morning. Individual GI symptoms include: gas/flatulence, abdominal cramping, abdominal distention/bloating, borborygmus/stomach rumbling, burping, and nausea and their severity is ranked on a 4-point scale ranging from none to severe.	Baseline, Days 1,2, 3,5,7 and 10 of each study product period.

External Links

•   American Academy of Pediatrics. Training and Education Module 6: Diarrhea and Dehydration.
•   Institute of Medicine. Dietary Reference Intakes for Energy, Carbohydrates, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids.
•   What We Eat in America, NHANES 2017-2018.
•   World Health Organization. Fact sheet: Diarrhoeal disease