Intestinal Microbiota and Barrier FunctionNCT02355210

Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults

A study testing Bifidobacteria adolescentis BD1, Bifidobacteria animalis subsp. lactis BB-12 and Bifidobacteria adolescentis BD1 and galactooligosaccharide in people with Intestinal Microbiota and Barrier Function, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the effect of a dietary supplement to improve gut health. The participants will take one of six dietary treatments for three weeks, and the gut bacteria and the gut intestinal barrier will be assessed to determine if these dietary treatments beneficially change these markers of gut health. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Intestinal Microbiota and Barrier Function
What is being tested?: Bifidobacteria adolescentis BD1, Bifidobacteria animalis subsp. lactis BB-12 and Bifidobacteria adolescentis BD1 and galactooligosaccharide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 151 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Oct 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18-65 yrs, obese (30 kg/m2 and greater)

Who cannot join

(1) prior intestinal resection, (2) patient history of GI diseases except for hiatal hernia, GERD, hemorrhoids, (3) severe renal disease defined by creatinine more than twice normal, (4) markedly abnormal liver function defined by ALT/AST over 4 times normal levels or elevated bilirubin (5) antibiotic use within the last 12 weeks prior to enrollment, (6) lean or overweight (BMI < 30 kg/m2), (7) intolerant to aspirin, (8) regular use of aspirin, (9) excessive alcohol intake (>2 drinks for men, 1 drink for women daily), (10) presence of uncontrolled chronic metabolic disease (cardiovascular disease, insulin requiring diabetes or uncontrolled diabetes, cancer, etc, (11) a plan to have a major change in dietary habit during the following 6 months, (12) consumption of probiotics, prebiotics or synbiotics without an appropriate 4 week washout period, (13) lactose intolerance or malabsorption; (14) subjects younger than 18 or older than 65, (15) unwillingness to consent to the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Application of a Novel Synbiotic to Modulate the Human Gut Microbiota and Improve Health

Read the detailed description

In this study, we intend to test the ecological and therapeutic functionality of a synbiotic combination of a Bifidobacterium adolescentis strain and the prebiotic galactooligosaccharide (GOS) in a human clinical trial. The synbiotic combination was selected based on a novel in vivo selection; specifically, the strain (BD1) is an human autochthonous gut organism that was enriched in an individual by GOS. Our experiments will test the efficacy of this synbiotic compared to a conventional synbiotic. We hypothesize this rationally selected synbiotic will improve intestinal barrier function in obese adult subjects, thereby preventing endotoxemia and metabolic inflammation, physiologically relevant functions that are increased in obese individuals. Our objectives are to: (1) compare the ability of the test and control synbiotic preparations to alter the gut microbiota in obese individuals; (2) test if GOS supports colonization and metabolic activity of test and control strains in the human gut; (3) compare the ability of the two synbiotic preparations to improve intestinal permeability and endotoxemia in obese subjects; and (4) assess associations between the gut microbiota and the test strain with biomarkers for translocation and endotoxemia.

Conditions: Intestinal Microbiota and Barrier Function
Being tested: Bifidobacteria adolescentis BD1, Bifidobacteria animalis subsp. lactis BB-12, Bifidobacteria adolescentis BD1 and galactooligosaccharide, Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide, galactooligosaccharide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bifidobacteria adolescentis BD1Dietary supplement
packet containing 10^9 cells of Bifidobacteria adolescentis BD1
Bifidobacteria animalis subsp. lactis BB-12Dietary supplement
packet containing 10^9 cells of Bifidobacteria animalis subsp. lactis BB-12
Bifidobacteria adolescentis BD1 and galactooligosaccharideDietary supplement
packet containing 10^9 cells Bifidobacteria adolescentis BD1 and 5 g galactooligosaccharide
Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharideDietary supplement
packet containing 10^9 cells B animalis subsp. lactis BB-12 and 5 g galactooligosaccharide
galactooligosaccharideDietary supplement
5 g galactooligosaccharide
PlaceboDietary supplement
lactose powder, 5 grams

Study groups in NCT02355210
Study group	Role	What they receive
Placebo	Placebo comparator	5 g lactose given as a placebo Receives: Dietary Supplement: Placebo
Probiotic 1	Experimental	Bifidobacteria adolescentis BD1, 10^9 Receives: Dietary Supplement: Bifidobacteria adolescentis BD1
Probiotic 2	Experimental	Bifidobacteria animalis subsp. lactis BB-12, 10^9 Receives: Dietary Supplement: Bifidobacteria animalis subsp. lactis BB-12
Prebiotic	Experimental	galactooligosaccaride, 5 g Receives: Dietary Supplement: galactooligosaccharide
Synbiotic 1	Experimental	galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10^9) Receives: Dietary Supplement: Bifidobacteria adolescentis BD1 and galactooligosaccharide
Synbiotic 2	Experimental	galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10^9) Receives: Dietary Supplement: Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12
change in microbiota composition, including presence of B. adolescentis BD1 and B. animalis supsp lactis BB-12
Measured: baseline and three weeks
Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine
Change in intestinal permeability as measured by change in percent sugars in urine
Measured: baseline and three weeks

Secondary outcomes (1)

Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein
Endotoxemia, as measured by change in circulating endotoxin by lipopolysaccharide and lipopolysaccharide-binding protein
Measured: baseline and three weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Oct 2015

First posted4 Feb 2015 (estimated)
Study startJun 2013
Primary completionAug 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Intestinal Microbiota and Barrier FunctionStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02355210
Sponsor's protocol ID: USDA-NIFA-AFRI-003397
Status last verified: Nov 2021
First submitted: 30 Jan 2015
Last updated: 23 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Krumbeck JA, Rasmussen HE, Hutkins RW, Clarke J, Shawron K, Keshavarzian A, Walter J. Probiotic Bifidobacterium strains and galactooligosaccharides improve intestinal barrier function in obese adults but show no synergism when used together as synbiotics. Microbiome. 2018 Jun 28;6(1):121. doi: 10.1186/s40168-018-0494-4.
PubMed 29954454

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
Active, not recruiting
The Impact of Postbiotic Supplementation on Tolerability and Physiological/Metabolic Parameters
Gastrointestinal Health
Recruiting
Mechanism of FODMAP Restriction on FGID Patients
Functional Gastrointestinal Disorders (FGIDs), Irritable Bowel Syndrome (IBS)
Recruiting
Effects of Probiotic Supplementation on Gut Health, Immune Response, and Well-Being
Gut Microbiome, Immune Responses
Not yet recruitingObservational study
Untreated Parkinson's Disease Work-up Assessing Resident Microbiota and Duodenal Barrier Function
Parkinson's Disease (PD)

All Intestinal Microbiota and Barrier Function trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of a Novel Synbiotic to Modulate the Human Gut Microbiota and Improve Health
ClinicalTrials.gov ID: NCT02355210
Acronym / sponsor ID: USDA-NIFA-AFRI-003397
Conditions: Intestinal Microbiota and Barrier Function
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Collaborators: University of Nebraska Lincoln, University of Alberta
Study start: Jun 2013
Primary completion: Aug 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 4 Feb 2015 (estimated)
Results: Posted 23 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Dietary Supplement: Placebo5 g lactose given as a placebo
Probiotic 1	Experimental	Dietary Supplement: Bifidobacteria adolescentis BD1Bifidobacteria adolescentis BD1, 10^9
Probiotic 2	Experimental	Dietary Supplement: Bifidobacteria animalis subsp. lactis BB-12Bifidobacteria animalis subsp. lactis BB-12, 10^9
Prebiotic	Experimental	Dietary Supplement: galactooligosaccharidegalactooligosaccaride, 5 g
Synbiotic 1	Experimental	Dietary Supplement: Bifidobacteria adolescentis BD1 and galactooligosaccharidegalacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10^9)
Synbiotic 2	Experimental	Dietary Supplement: Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharidegalacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10^9)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

18-65 yrs, obese (30 kg/m2 and greater)

Key exclusion criteria (1 listed)

(1) prior intestinal resection, (2) patient history of GI diseases except for hiatal hernia, GERD, hemorrhoids, (3) severe renal disease defined by creatinine more than twice normal, (4) markedly abnormal liver function defined by ALT/AST over 4 times normal levels or elevated bilirubin (5) antibiotic use within the last 12 weeks prior to enrollment, (6) lean or overweight (BMI < 30 kg/m2), (7) intolerant to aspirin, (8) regular use of aspirin, (9) excessive alcohol intake (>2 drinks for men, 1 drink for women daily), (10) presence of uncontrolled chronic metabolic disease (cardiovascular disease, insulin requiring diabetes or uncontrolled diabetes, cancer, etc, (11) a plan to have a major change in dietary habit during the following 6 months, (12) consumption of probiotics, prebiotics or synbiotics without an appropriate 4 week washout period, (13) lactose intolerance or malabsorption; (14) subjects younger than 18 or older than 65, (15) unwillingness to consent to the study.

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
Bifidobacteria adolescentis BD1packet containing 10^9 cells of Bifidobacteria adolescentis BD1	Dietary supplement	Probiotic 1
Bifidobacteria animalis subsp. lactis BB-12packet containing 10^9 cells of Bifidobacteria animalis subsp. lactis BB-12	Dietary supplement	Probiotic 2
Bifidobacteria adolescentis BD1 and galactooligosaccharidepacket containing 10^9 cells Bifidobacteria adolescentis BD1 and 5 g galactooligosaccharide	Dietary supplement	Synbiotic 1
Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharidepacket containing 10^9 cells B animalis subsp. lactis BB-12 and 5 g galactooligosaccharide	Dietary supplement	Synbiotic 2
galactooligosaccharide5 g galactooligosaccharide	Dietary supplement	Prebiotic
Placebolactose powder, 5 grams	Dietary supplement	Placebo

Primary outcome

Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12
Time frame: baseline and three weeks
change in microbiota composition, including presence of B. adolescentis BD1 and B. animalis supsp lactis BB-12
Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine
Time frame: baseline and three weeks
Change in intestinal permeability as measured by change in percent sugars in urine

1 secondary outcome

Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein
Time frame: baseline and three weeks

Results and safety

Results posted to the registry on 23 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	19	19
Probiotic 1	18	18
Probiotic 2	16	16
Synbiotic 1	17	17
Synbiotic 2	19	19
Prebiotic	18	18

Primary outcome: Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12

Time frame: baseline and three weeks. Mean (Standard Deviation). Unit: percentage of bacterial taxa

Measure	Placebo n = 17	Probiotic 1 n = 14	Probiotic 2 n = 14	Synbiotic 1 n = 16	Synbiotic 2 n = 17	Prebiotic n = 16
Bifidobacterium Baseline	7.9 (8.1)	9.1 (5.3)	8.8 (5.7)	6.0 (5.9)	8.7 (6.2)	11.3 (10.5)
Bifidobacterium Treatment End	12.0 (8.0)	14.6 (6.9)	9.5 (8.4)	14.7 (7.4)	15.9 (8.0)	17.4 (11.4)
OTU_1 (B adolescentis) Baseline	1.2 (1.9)	1.2 (4.2)	1.2 (2.5)	2.5 (4.5)	3.1 (4.5)	3.8 (7.5)
OTU_1 (B adolescentis) Treatment End	2.6 (4.1)	3.4 (5.1)	1.1 (1.6)	7.3 (7.0)	6.8 (9.6)	6.6 (8.8)
OTU_167 (B. animalis subsp. lactis) Baseline	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)
OTU_167 (B. animalis subsp. lactis) Treatment End	0.0 (0.1)	0.0 (0.0)	0.1 (0.1)	0.0 (0.0)	0.1 (0.2)	0.2 (0.9)

Population analysed: Mann-Whitney-Wilcoxon matched pair tests

Primary outcome: Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine

Time frame: baseline and three weeks. Mean (Standard Deviation). Unit: sucralose:lactulose ratio

Measure	Placebo n = 17	Probiotic 1 n = 14	Probiotic 2 n = 14	Synbiotic 1 n = 16	Synbiotic 2 n = 17	Prebiotic n = 16
Sucralose:Lactulose with aspirin Baseline	0.32 (0.20)	0.34 (0.21)	0.34 (0.30)	0.32 (0.23)	0.36 (0.19)	0.37 (0.19)
Sucralose:Lactulose with aspirin Treatment End	0.36 (0.25)	0.20 (0.16)	0.26 (0.18)	0.20 (0.16)	0.29 (0.16)	0.23 (0.15)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Probiotic 1	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Probiotic 2	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Synbiotic 1	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Synbiotic 2	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Prebiotic	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29954454Krumbeck JA, Rasmussen HE, Hutkins RW, Clarke J, Shawron K, Keshavarzian A, Walter J. Probiotic Bifidobacterium strains and galactooligosaccharides improve intestinal barrier function in obese adults but show no synergism when used together as synbiotics. Microbiome. 2018 Jun 28;6(1):121. doi: 10.1186/s40168-018-0494-4.

Related trials for Intestinal Microbiota and Barrier Function

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The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
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The Impact of Postbiotic Supplementation on Tolerability and Physiological/Metabolic Parameters
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Mechanism of FODMAP Restriction on FGID Patients
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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.

Robert Hutkins, PhD principal investigator

University of Nebraska Lincoln

Jens Walter, PhD principal investigator

University of Alberta

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 23 Nov 2021. 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. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 (time frame: baseline and three weeks). The study lists 2 primary outcomes in all. 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 NCT02355210, 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 23 Nov 2021.