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

NCT ID: NCT01870544

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-01-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LGG Administration

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.

Group Type: EXPERIMENTAL

Lactobacillus Rhamnosus GG

Intervention Type: DIETARY_SUPPLEMENT

LGG will be administered orally for 44 days

Placebo

Placebo to be taken orally for 44 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo will be administered daily for 44 days

Interventions

Lactobacillus Rhamnosus GG

LGG will be administered orally for 44 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo

placebo will be administered daily for 44 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shira Doron, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center Weight and Wellness Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

Tufts Obesity Study

Identifier Type: -

Identifier Source: org_study_id