Does Weight Loss Surgery and Probiotic Supplementation Lead to a "Lean" Gut Microbiota?

Tufts University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus Rhamnosus GG

Study type: Interventional

Funder types: Other

Identifiers

NCT01870544

Tufts Obesity Study

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

LGG Administration

Experimental group

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.

Treatment:

Dietary Supplement: Lactobacillus Rhamnosus GG

Placebo

Placebo Comparator group

Description:

Placebo to be taken orally for 44 days.

Treatment:

Dietary Supplement: Placebo