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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04100460
Other study ID # BIO-1907
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2019
Est. completion date May 2020

Study information

Verified date September 2019
Source Comet Bio Inc.
Contact Kristen Sanoshy
Phone 630-330-0463
Email kristen.sanoshy@mxns.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to investigate the effect on Arabinoxylan on gastrointestinal (GI) tolerance, bowel habits, and microbiota in adults. The study is a randomized, placebo-controlled, crossover, single-center trial with 3 study periods separated by minimum 2-week washout periods. 45 healthy adults will be recruited for the trial. Participants will be required to drink a beverage twice a day for 3 weeks during each study period. The beverage will contain either approximately 7.25 grams of Arabinoxylan leaf fiber extract per day, or approximately 14.5 grams of Arabinoxylan leaf fiber extract per day, or will not contain any Arabinoxylan (control). Subjects will record their bowel movements daily, fill out daily questionnaires about their gastrointestinal systems, and record their food intake at specified times during the study. Stool samples will also be collected prior to and at the end of each study period for analysis of bacteria composition.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
7.25 grams of Arabinoxylan leaf fiber extract
Participants are given 7.25 grams of Arabinoxylan daily
14.5 grams of Arabinoxylan leaf fiber extract
Participants are given 14.5 grams of Arabinoxylan daily
Control - No Arabinoxylan
Participants are given no Arabinoxylan

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Comet Bio Inc. Biofortis, Merieux NutriSciences

References & Publications (1)

Trumbo P, Schlicker S, Yates AA, Poos M; Food and Nutrition Board of the Institute of Medicine, The National Academies. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc. 2002 Nov;102(11):1621-30. Erratum in: J Am Diet Assoc. 2003 May;103(5):563. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary GI Symptoms Score Composite GI symptoms Scores obtained from the Daily GI Tolerance Questionnaire will be obtained by summing the ratings to the 8 individual scores (see below in Outcome 2). 3 weeks +/- 3 days
Primary Individual GI symptoms ratings Ratings for each of the 8 individual GI symptoms Scores [gas/flatulence, nausea, vomiting, abdominal cramping, abdominal distention/bloating, borborygmus/stomach rumbling, burping, and/or reflux (heartburn)] will be ranked on a 4-point scale (none, mild, moderate, severe) for symptoms experienced over the previous 24 hours. 3 weeks +/- 3 days
Secondary Bowel Habits Dairy Compilation of bowel habits obtained by each subject's Bowel Habits Diary 3 weeks +/- 3 days
Secondary Fecal Microbiome Results of the stool samples that will examine diversity, composition, and changes in bacteria. 3 weeks +/- 3 days
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