Status:
COMPLETED
Does Weight Loss Surgery and Probiotic Supplementation Lead to a "Lean" Gut Microbiota?
Lead Sponsor:
Tufts Medical Center
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 gast...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01870544
Start Date
September 1 2013
End Date
January 1 2016
Last Update
February 10 2016
Active Locations (1)
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1
Tufts Medical Center Weight and Wellness Center
Boston, Massachusetts, United States, 02111