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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Lactobacillus Rhamnosus GG; Dietary Supplement: Placebo

• Registration Number: NCT01870544
• Lead Sponsor: Tufts Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-06
• Study Start: 2013-09
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LGG Administration	Lactobacillus Rhamnosus GG	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	Placebo	Placebo to be taken orally for 44 days.

Primary Outcome Measures

Name	Time	Method
Weight Loss	4 months

Secondary Outcome Measures

Name	Time	Method
Percentage of Bacteria Phyla	4 months	We will specifically look at the percentages of different bacterial phyla in the stool and intestine

Trial Locations

Locations (1)

Tufts Medical Center Weight and Wellness Center; 🇺🇸 Boston, Massachusetts, United States