Gastrointestinal ToleranceNCT05213494
The Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children
A study testing Inulin and soluble corn fiber in people with Gastrointestinal Tolerance, run by Tate & Lyle at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Inulin and soluble corn fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 28 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female, 3-9 years of age, inclusive at Visit 1 (Day -7)
- Potty trained
- Bowel movement at least every other day.
- Regularly consumes breakfast (at least 5 times/week) and agrees to consume breakfast every day during each test period.
- Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial.
- Willing to refrain from exclusionary medications, supplements, and products throughout the study.
- 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.
- 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.
Who cannot join
- 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.
- 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.
- 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)].
- 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).
- 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.
- 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.
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- 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.
- Extreme dietary habits as determined using the Diet Questionnaire (Appendix 2) and at the discretion of the Clinical Investigator.
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Major trauma or any other surgical event within 3 months of Visit 1 (Day -7).
- 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).*
- Weight loss or gain >4.5 kg in the 3 months prior to Visit 1 (Day -7).
- Currently or planning to be on a weight loss regimen during the study.
- Antibiotic use within 3 months of Visit 1 (Day -7).
- Use of steroids within 1 month of Visit 1 (Day -7).
- Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDs) within 1 month of Visit 1 (Day -7).
- 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.
- Use of allergy medications (prescription or over the counter) for >2 times/week within 2 weeks of Visit 1 (Day -7).
- Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -7).
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Innovation Services
Addison, Illinois, 60101
About this study
Official title: A Randomized, Controlled, Crossover Study to Assess the Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children
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.
Read the detailed 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.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Inulin, soluble corn fiber
- Keywords
- digestion, fiber, tolerance,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinOther
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 fiberOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose inulin | Active comparator | 3-5 years old: 3g of fiber/day from inulin mixed in a beverage 6-9 years old: 5g of fiber/day from inulin mixed in a beverage Receives: Other: Inulin |
| Low-dose soluble corn fiber | Experimental | 3-5 years old: 3g of fiber/day from soluble corn fiber mixed in a beverage 6-9 years old: 5g of fiber/day from soluble corn fiber mixed in a beverage Receives: Other: soluble corn fiber |
| High-dose inulin | Active comparator | 3-5 years old: 6g of fiber/day from inulin mixed in a beverage 6-9 years old: 8g of fiber/day from inulin mixed in a beverage Receives: Other: Inulin |
| High-dose soluble corn fiber | Experimental | 3-5 years old: 6g of fiber/day from soluble corn fiber mixed in a beverage 6-9 years old: 8g of fiber/day from soluble corn fiber mixed in a beverage Receives: Other: soluble corn fiber |
| Baseline | No intervention | 3-9 years old: pre-intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 day study period
Secondary outcomes (1)
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.
Measured: Baseline, Days 1,2, 3,5,7 and 10 of each study product period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start20 May 2021
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tate & Lyle
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Innovation Services
- Responsible party
- Sponsor
- Investigators
- Kathleen Kelley, Principal investigator, Biofortis Innovation Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213494
- Sponsor's protocol ID
- BIO-2108
- Status last verified
- Jan 2022
- First submitted
- 30 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aziz I, Whitehead WE, Palsson OS, Tornblom H, Simren 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.
PubMed 31893959Boler 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.
PubMed 21736814So 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.
PubMed 29757343Ho 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.
PubMed 31188437Housez 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.
PubMed 22672058Karalus 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.
PubMed 22771185Klosterbuer 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.
PubMed 23388502Klurfeld 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.
PubMed 30130151Molly 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. doi: 10.1007/BF00228615.
PubMed 7763732Stewart 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.
PubMed 20090313Timm 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.
PubMed 23427334Van 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.
PubMed 32830554Whisner 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.
PubMed 24848974
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Crossover Study to Assess the Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children
- ClinicalTrials.gov ID
- NCT05213494
- Acronym / sponsor ID
- BIO-2108
- Conditions
- Gastrointestinal Tolerance
- Keywords
- digestion, fiber, tolerance,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tate & LyleIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Innovation Services
- Study start
- 20 May 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low-dose inulin | Active comparator | Other: Inulin3-5 years old: 3g of fiber/day from inulin mixed in a beverage 6-9 years old: 5g of fiber/day from inulin mixed in a beverage |
| Low-dose soluble corn fiber | Experimental | Other: soluble corn fiber3-5 years old: 3g of fiber/day from soluble corn fiber mixed in a beverage 6-9 years old: 5g of fiber/day from soluble corn fiber mixed in a beverage |
| High-dose inulin | Active comparator | Other: Inulin3-5 years old: 6g of fiber/day from inulin mixed in a beverage 6-9 years old: 8g of fiber/day from inulin mixed in a beverage |
| High-dose soluble corn fiber | Experimental | Other: soluble corn fiber3-5 years old: 6g of fiber/day from soluble corn fiber mixed in a beverage 6-9 years old: 8g of fiber/day from soluble corn fiber mixed in a beverage |
| Baseline | No intervention | –3-9 years old: pre-intervention. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female, 3-9 years of age, inclusive at Visit 1 (Day -7)
- Potty trained
- Bowel movement at least every other day.
- Regularly consumes breakfast (at least 5 times/week) and agrees to consume breakfast every day during each test period.
- Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial.
Key exclusion criteria (29 listed)
- 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.
- 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.
- 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)].
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InulinInulin, a dietary fiber, will be given in a beverage daily in doses 3g, 5g, 6g, or 8g dependent on arm and age of participants. | Other | High-dose inulin, Low-dose inulin |
| soluble corn fibersoluble 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. | Other | High-dose soluble corn fiber, Low-dose soluble corn fiber |
Primary outcome
GI Tolerance Composite Score
Time frame: 10 day study period
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.
1 secondary outcome
Effects of consuming soluble corn fiber on individual GI symptoms
Time frame: Baseline, Days 1,2, 3,5,7 and 10 of each study product period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Background: PubMed 31893959Aziz I, Whitehead WE, Palsson OS, Tornblom H, Simren 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.
- Background: PubMed 21736814Boler 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.
- Background: PubMed 29757343So 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.
- Background: PubMed 31188437Ho 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.
- Background: PubMed 22672058Housez 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.
- Background: PubMed 22771185Karalus 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.
- Background: PubMed 23388502Klosterbuer 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.
- Background: PubMed 30130151Klurfeld 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.
- Background: PubMed 7763732Molly 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. doi: 10.1007/BF00228615.
- Background: PubMed 20090313Stewart 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.
- Background: PubMed 23427334Timm 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.
- Background: PubMed 32830554Van 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.
- Institute of Medicine. Dietary Reference Intakes for Energy, Carbohydrates, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids.Link provided by the sponsor.
- What We Eat in America, NHANES 2017-2018.Link provided by the sponsor.
- World Health Organization. Fact sheet: Diarrhoeal diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Kelley principal investigator
Biofortis Innovation Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin and soluble corn fiber in people with Gastrointestinal Tolerance, run by Tate & Lyle at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI Tolerance Composite Score (time frame: 10 day study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05213494, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.