NCT01870544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Sep 2013

Typical duration for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

2.3 years

First QC Date

May 13, 2013

Last Update Submit

February 9, 2016

Conditions

Obesity

Keywords

gastric bypassmicrobiotaprobiotic

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    4 months

Secondary Outcomes (1)

  • Percentage of Bacteria Phyla

    4 months

Study Arms (2)

LGG Administration

EXPERIMENTAL

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.

Dietary Supplement: Lactobacillus Rhamnosus GG

Placebo

PLACEBO COMPARATOR

Placebo to be taken orally for 44 days.

Dietary Supplement: Placebo

Interventions

Lactobacillus Rhamnosus GGDIETARY_SUPPLEMENT

LGG will be administered orally for 44 days

LGG Administration
PlaceboDIETARY_SUPPLEMENT

placebo will be administered daily for 44 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center Weight and Wellness Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shira Doron, MD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

June 6, 2013

Study Start

September 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations

US(1)