ObesityPhase 1/2NCT01870544
Does Weight Loss Surgery and Probiotic Supplementation Lead to a "Lean" Gut Microbiota?
A Phase 1/2 study testing Lactobacillus Rhamnosus GG in people with Obesity, run by Tufts Medical Center at 1 site in United States.
Trial summary
The purpose of the weight-loss study is to characterize the effect of LGG supplementation on the relative abundance of phyla in the gut microbiota of patients undergoing gastric bypass and sleeve gastrectomy surgery, and to elucidate a relationship between the gut microbiota pattern and the degree of weight-loss… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Lactobacillus Rhamnosus GG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jan 2016
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Able to give informed consent and report on side effects
- Tolerating an oral/enteral diet
- Stable comorbid conditions
- Outpatient
Who cannot join
- Inpatients
- Pregnancy (urine test done on all patients routinely pre-op)/ unwilling to comply with contraceptive requirement after gastric bypass surgery
- Known use of LGG or another probiotic (not including yogurt) within the previous 30 days
- Presence of an active bowel leak, acute abdomen, active intestinal disease, or significant bowel dysfunction
- Presence of an absolute neutrophil count less than 500 per cubic mm (must have had a Complete Blood Count within the last 6 months) or anticipation post chemotherapy that the absolute neutrophil count will fall below 500 per cubic mm.
- History of adverse reaction to product containing lactobacillus
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- Active colitis (*see definition below)
- Known or suspected allergies to probiotics, lactobacillus, milk protein, or microcrystalline cellulose
- Structural heart disease, history of endocarditis or valve replacement, implanted cardiac device, congestive heart failure
- Positive baseline stool culture for LGG
- Recent or planned chemotherapy or radiation therapy
- Solid organ transplant within the prior year
- Stem cell transplant within the prior year
- On active immunosuppressive medication [anti-rejection, injectable immunosuppressive drugs for autoimmune disease, or corticosteroids (greater than ½ mg per kg body weight of prednisone or its equivalent) not including inhaled or topical steroids]
- Allergy or intolerance to or contraindication to two or more of the rescue antibiotic regimens (ampicillin, clindamycin, moxifloxacin)
- Participating in another clinical trial
- Uncontrolled psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center Weight and Wellness Center
Boston, Massachusetts, 02111
About this study
The purpose of the weight-loss study is to characterize the effect of LGG supplementation on the relative abundance of phyla in the gut microbiota of patients undergoing gastric bypass and sleeve gastrectomy surgery, and to elucidate a relationship between the gut microbiota pattern and the degree of weight-loss post-surgery.
The investigators hypothesize that LGG administration will result in a "leaner" pattern of gut microbiota that will lead to higher weight loss at 3 months post-surgery.
- Conditions
- Obesity
- Being tested
- Lactobacillus Rhamnosus GG, Placebo
- Keywords
- gastric bypass, microbiota, probiotic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Rhamnosus GGDietary supplement
LGG will be administered orally for 44 days
PlaceboDietary supplement
placebo will be administered daily for 44 days
| Study group | Role | What they receive |
|---|---|---|
| LGG Administration | Experimental | Lactobacillus Rhamnosus GG (LGG) will be taken orally for 44 days. The daily dose is 2*10^10 organisms. The LGG is contained in capsules (1*10^10 organisms per capsule), and two capsules will be taken per day. Receives: Dietary Supplement: Lactobacillus Rhamnosus GG |
| Placebo | Placebo comparator | Placebo to be taken orally for 44 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measured: 4 months
Secondary outcomes (1)
Percentage of Bacteria Phyla
We will specifically look at the percentages of different bacterial phyla in the stool and intestine
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shira Doron, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870544
- Sponsor's protocol ID
- Tufts Obesity Study
- Status last verified
- Feb 2016
- First submitted
- 13 May 2013
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Weight Loss Surgery and Probiotic Supplementation Lead to a "Lean" Gut Microbiota?
- ClinicalTrials.gov ID
- NCT01870544
- Acronym / sponsor ID
- Tufts Obesity Study
- Conditions
- Obesity
- Keywords
- gastric bypass, microbiota, probiotic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Jun 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.
The purpose of the weight-loss study is to characterize the effect of LGG supplementation on the relative abundance of phyla in the gut microbiota of patients undergoing gastric bypass and sleeve gastrectomy surgery, and to elucidate a relationship between the gut microbiota pattern and the degree of weight-loss post-surgery.
The investigators hypothesize that LGG administration will result in a "leaner" pattern of gut microbiota that will lead to higher weight loss at 3 months post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGG Administration | Experimental | Dietary Supplement: Lactobacillus Rhamnosus GGLactobacillus Rhamnosus GG (LGG) will be taken orally for 44 days. The daily dose is 2*10^10 organisms. The LGG is contained in capsules (1*10^10 organisms per capsule), and two capsules will be taken per day. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo to be taken orally for 44 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 18 years
- Able to give informed consent and report on side effects
- Tolerating an oral/enteral diet
- Stable comorbid conditions
- Outpatient
Key exclusion criteria (17 listed)
- Inpatients
- Pregnancy (urine test done on all patients routinely pre-op)/ unwilling to comply with contraceptive requirement after gastric bypass surgery
- Known use of LGG or another probiotic (not including yogurt) within the previous 30 days
- Presence of an active bowel leak, acute abdomen, active intestinal disease, or significant bowel dysfunction
- Presence of an absolute neutrophil count less than 500 per cubic mm (must have had a Complete Blood Count within the last 6 months) or anticipation post chemotherapy that the absolute neutrophil count will fall below 500 per cubic mm.
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 |
|---|---|---|
| Lactobacillus Rhamnosus GGLGG will be administered orally for 44 days | Dietary supplement | LGG Administration |
| Placeboplacebo will be administered daily for 44 days | Dietary supplement | Placebo |
Primary outcome
Weight Loss
Time frame: 4 months
1 secondary outcome
Percentage of Bacteria Phyla
Time frame: 4 months
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 10 Feb 2016.
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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.
Shira Doron, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lactobacillus Rhamnosus GG in people with Obesity, run by Tufts Medical Center at 1 site 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 5 inclusion and 17 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 10 Feb 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Weight Loss (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2016.