Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Bifidobacteria, Healthy Volunteers

In brief

Human and animal studies demonstrate that xylooligosaccharides (XOS) are a highly efficacious prebiotic ingredient that delivers benefits at a minimum level of 1.4 g/day (d), which is much lower than levels required by fructooligosaccharides (FOS, 5 g/d) or galactooligosaccharides (GOS, 8 g/d). XOS promotes gastrointestinal regularity and relieves diarrhea and constipation at 0.7 g/d and 1.4 g/d, respectively. Xylooligosaccharides may also reduce blood cholesterol and may improve glycemic control, although more data from clinical trials are needed to confirm preliminary findings.

Key facts

Study ID

NCT01861964

Run by

University of California, Los Angeles

People needed

30

Starts

2012-02-01

Expected to finish

2013-01-01

Last updated by the study team

2016-11-28

Who can join

Age: 20 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 20-50 years of age at screen.
• In generally good health
• Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.

You may not qualify if…

• Any history of gastrointestinal disease except for appendectomy
• No antibiotic, pre- or probiotic or laxative use during the 2 months before the study.
• Any subject with a history of diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
• Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
• Any subject who currently uses tobacco products.
• Any subject who is pregnant or lactating, or becomes pregnant during the study.
• Any subject who is unable or unwilling to comply with the study protocol.

Where it is running

• UCLA Center for Human Nutriiton — Los Angeles, California, United States
• UCLA Center for Human Nutrition, David Geffen School of Medicine — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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