Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora (XOS)

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Healthy Volunteers; Bifidobacteria

Treatments: Dietary Supplement: Placebo (Maltodextrin); Dietary Supplement: Xylooligosarcharide 2.8g; Dietary Supplement: Xylooligosarcharide 1.4g

Study type: Interventional

Funder types: Other

Identifiers

NCT01861964

LBIXOS001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 20-50 years of age at screen.
2. In generally good health
3. 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.

Exclusion criteria

1. Any history of gastrointestinal disease except for appendectomy
2. No antibiotic, pre- or probiotic or laxative use during the 2 months before the study.
3. 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.
4. Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
5. Any subject who currently uses tobacco products.
6. Any subject who is pregnant or lactating, or becomes pregnant during the study.
7. Any subject who is unable or unwilling to comply with the study protocol.

Trial design

30 participants in 3 patient groups, including a placebo group

Sugar Pill

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo (Maltodextrin)

Xylooligosarcharide 2.8g

Active Comparator group

Description:

Xylooligosarcharide 2.8grams

Treatment:

Dietary Supplement: Xylooligosarcharide 2.8g

Xylooligosarcharide 1.4g

Active Comparator group

Treatment:

Dietary Supplement: Xylooligosarcharide 1.4g