BifidobacteriaPhase 2/3XOSNCT01861964
Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora
A Phase 2/3 study testing Xylooligosarcharide 1.4g and Xylooligosarcharide 2.8g in people with Bifidobacteria and Healthy Volunteers, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bifidobacteria, Healthy Volunteers
- What is being tested?
- Xylooligosarcharide 1.4g and Xylooligosarcharide 2.8g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Jan 2013
- Phase
- Phase 2/3
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA Center for Human Nutriiton
Los Angeles, California, 90095
UCLA Center for Human Nutrition, David Geffen School of Medicine
Los Angeles, California, 90095
About this study
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.
- Conditions
- Bifidobacteria, Healthy Volunteers
- Being tested
- Placebo (Maltodextrin), Xylooligosarcharide 1.4g, Xylooligosarcharide 2.8g
- Keywords
- XOS, Xylooligosarcharide, Prebiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (Maltodextrin)Dietary supplement
Also called Maltodextrin
Maltodextrin 505mg/capsule 8 capsules/day (4 with breakfast and 4 with dinner meal)
Xylooligosarcharide 1.4gDietary supplement
Also called XOS 1.4g
8 capsules (512 mg/capsule) 4 with breakfast and 4 with dinner meal
Xylooligosarcharide 2.8gDietary supplement
Also called XOS 2.8g
8 capsules (520 mg/capsule) to be taken in the morning and in the evening
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Not described Receives: Dietary Supplement: Placebo (Maltodextrin) |
| Xylooligosarcharide 2.8g | Active comparator | Xylooligosarcharide 2.8grams Receives: Dietary Supplement: Xylooligosarcharide 2.8g |
| Xylooligosarcharide 1.4g | Active comparator | Not described Receives: Dietary Supplement: Xylooligosarcharide 1.4g |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of Xyloologosarcharide (XOS) on colonic bifidobacteria counts in healthy volunteers.
After a 2 weeks of run-in, 30 healthy volunteers were randomly assigned to take 1.4 grams/day of XOS, or 2.8 grams/day or placebo for 8 weeks. The bifidobarteria counts was assessed at screening, baseline, 4, 8 weeks on supplementation of XOS and after 2 week cessation of XOS.
Measured: 10 weeks
Secondary outcomes (1)
Tolerance of XOS by healthy volunteers
The tolerance of XOS was assessed by questionnaires, adverse event logs with comparison with placebo control group
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BifidobacteriaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 2/3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Heber, MD, PhD, Principal investigator, UCLA Center for Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861964
- Sponsor's protocol ID
- LBIXOS001
- Acronym
- XOS
- Status last verified
- Nov 2016
- First submitted
- 8 May 2013
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Finegold SM, Li Z, Summanen PH, Downes J, Thames G, Corbett K, Dowd S, Krak M, Heber D. Xylooligosaccharide increases bifidobacteria but not lactobacilli in human gut microbiota. Food Funct. 2014 Mar;5(3):436-45. doi: 10.1039/c3fo60348b.
PubMed 24513849
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora
- ClinicalTrials.gov ID
- NCT01861964
- Acronym / sponsor ID
- XOS / LBIXOS001
- Conditions
- Bifidobacteria, Healthy Volunteers
- Keywords
- XOS, Xylooligosarcharide, Prebiotic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 May 2013 (estimated)
- 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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Dietary Supplement: Placebo (Maltodextrin) |
| Xylooligosarcharide 2.8g | Active comparator | Dietary Supplement: Xylooligosarcharide 2.8gXylooligosarcharide 2.8grams |
| Xylooligosarcharide 1.4g | Active comparator | Dietary Supplement: Xylooligosarcharide 1.4g |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Placebo (Maltodextrin)Also: MaltodextrinMaltodextrin 505mg/capsule 8 capsules/day (4 with breakfast and 4 with dinner meal) | Dietary supplement | Sugar Pill |
| Xylooligosarcharide 1.4gAlso: XOS 1.4g8 capsules (512 mg/capsule) 4 with breakfast and 4 with dinner meal | Dietary supplement | Xylooligosarcharide 1.4g |
| Xylooligosarcharide 2.8gAlso: XOS 2.8g8 capsules (520 mg/capsule) to be taken in the morning and in the evening | Dietary supplement | Xylooligosarcharide 2.8g |
Primary outcome
The Effects of Xyloologosarcharide (XOS) on colonic bifidobacteria counts in healthy volunteers.
Time frame: 10 weeks
After a 2 weeks of run-in, 30 healthy volunteers were randomly assigned to take 1.4 grams/day of XOS, or 2.8 grams/day or placebo for 8 weeks. The bifidobarteria counts was assessed at screening, baseline, 4, 8 weeks on supplementation of XOS and after 2 week cessation of XOS.
1 secondary outcome
Tolerance of XOS by healthy volunteers
Time frame: 10 weeks
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 Nov 2016.
- Results publication: PubMed 24513849Finegold SM, Li Z, Summanen PH, Downes J, Thames G, Corbett K, Dowd S, Krak M, Heber D. Xylooligosaccharide increases bifidobacteria but not lactobacilli in human gut microbiota. Food Funct. 2014 Mar;5(3):436-45. doi: 10.1039/c3fo60348b.
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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.
David Heber, MD, PhD principal investigator
UCLA Center for Human Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Xylooligosarcharide 1.4g and Xylooligosarcharide 2.8g in people with Bifidobacteria and Healthy Volunteers, run by University of California, Los Angeles at 2 sites 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 3 inclusion and 7 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The Effects of Xyloologosarcharide (XOS) on colonic bifidobacteria counts in healthy volunteers. (time frame: 10 weeks). 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 NCT01861964, which also lists 1 linked publication.
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 Nov 2016.