Back to resultsDoes Weight Loss Surgery and Probiotic Supplementation Lead to a "Lean" Gut Microbiota?
Primary Purpose
Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus Rhamnosus GG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring gastric bypass, microbiota, probiotic
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Tufts Medical Center Weight and Wellness Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LGG Administration
Placebo
Arm Description
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.
Placebo to be taken orally for 44 days.
Outcomes
Primary Outcome Measures
Weight Loss
Secondary Outcome Measures
Percentage of Bacteria Phyla
We will specifically look at the percentages of different bacterial phyla in the stool and intestine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01870544
Brief Title
Does Weight Loss Surgery and Probiotic Supplementation Lead to a "Lean" Gut Microbiota?
Official Title
Does Weight Loss Surgery and Probiotic Supplementation Lead to a "Lean" Gut Microbiota?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
gastric bypass, microbiota, probiotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LGG Administration
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to be taken orally for 44 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus Rhamnosus GG
Intervention Description
LGG will be administered orally for 44 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
placebo will be administered daily for 44 days
Primary Outcome Measure Information:
Title
Weight Loss
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Percentage of Bacteria Phyla
Description
We will specifically look at the percentages of different bacterial phyla in the stool and intestine
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shira Doron, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center Weight and Wellness Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
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Does Weight Loss Surgery and Probiotic Supplementation Lead to a "Lean" Gut Microbiota?
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