Obesity
Conditions
Keywords
gastric bypass, microbiota, probiotic
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus Rhamnosus GG
LGG will be administered orally for 44 days
DIETARY_SUPPLEMENTPlacebo
placebo will be administered daily for 44 days
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years 2. Able to give informed consent and report on side effects 3. Tolerating an oral/enteral diet 4. Stable comorbid conditions 5. Outpatient
Exclusion criteria
1. Inpatients 2. Pregnancy (urine test done on all patients routinely pre-op)/ unwilling to comply with contraceptive requirement after gastric bypass surgery 3. Known use of LGG or another probiotic (not including yogurt) within the previous 30 days 4. Presence of an active bowel leak, acute abdomen, active intestinal disease, or significant bowel dysfunction 5. 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. 6. History of adverse reaction to product containing lactobacillus 7. Active colitis (\*see definition below) 8. Known or suspected allergies to probiotics, lactobacillus, milk protein, or microcrystalline cellulose 9. Structural heart disease, history of endocarditis or valve replacement, implanted cardiac device, congestive heart failure 10. Positive baseline stool culture for LGG 11. Recent or planned chemotherapy or radiation therapy 12. Solid organ transplant within the prior year 13. Stem cell transplant within the prior year 14. On active immunosuppressive medication \[anti-rejection, injectable immunosuppressive drugs for autoimmune disease, or corticosteroids (greater than ½ mg per kg body weight of prednisone or its equivalent) not including inhaled or topical steroids\] 15. Allergy or intolerance to or contraindication to two or more of the rescue antibiotic regimens (ampicillin, clindamycin, moxifloxacin) 16. Participating in another clinical trial 17. Uncontrolled psychiatric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight Loss | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Bacteria Phyla | 4 months | We will specifically look at the percentages of different bacterial phyla in the stool and intestine |
Countries
United States
Outcome results
None listed