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OpenTrials
Completed

NCT Number: NCT01870544

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tufts Medical Center Weight and Wellness Center

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Lactobacillus rhamnosus GG

Dietary Supplement

LGG will be administered orally for 44 days

Placebo

Dietary Supplement

placebo will be administered daily for 44 days

Primary outcomes

  1. Weight Loss

    Time frame: 4 months

Secondary outcomes

  1. Percentage of Bacteria Phyla

    Time frame: 4 months

    We will specifically look at the percentages of different bacterial phyla in the stool and intestine

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2013
Registry last updated
Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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