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Completed

NCT Number: NCT02654496

Gut Microbiota Post Roux-en-Y Gastric Bypass Surgery

The purpose of this study is to investigate mechanisms responsible for weight change in patients who have undergone weight loss surgery. Specifically, we will compare the gut microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS in three groups of subjects: 3-5 years post gastric bypass patients who experienced sub-optimal weight loss, 3-5 years post gastric bypass patients who had successful weight loss, and a control group who has not had a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass groups.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

North Dakota State University/Sanford Health

Fargo, North Dakota, 58103, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female
  • Age 18-65
  • 3-5 years post Roux-en-Y gastric bypass and experienced successful weight loss following surgery (up to n=10) or
  • 3-5 years post Roux-en-Y gastric bypass and did not experience optimal weight loss following surgery (up to n=10) or
  • Nonsurgical control participants who are approximately matched in sex, age, and BMI to the optimal weight loss group (up to n=10).

Exclusion criteria

  • Tobacco use in past three months.
  • Taking a medication which is known to significantly influence gastrointestinal transit time or affect the microbiome or other variables significantly (as determined by study pharmacist/MD).
  • History of diabetes mellitus.
  • Has taken an oral or IV/IM antibiotic in the past 3 months.
  • Has taken probiotic and/or prebiotic agent in the past 3 months
  • History of significant intestinal disease or disorder (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome)
  • History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator.
  • Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator.
  • Unable to speak/read English.
  • Breastfeeding, pregnant, or planning to become pregnant within the duration of the study.
  • Unwilling to use a medically acceptable form of contraception.
  • History of bipolar or psychotic spectrum disorder or alcohol or substance treatment in the past year

Treatment and study plan

Meal Challenge

Other

Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.

Primary outcomes

  1. Intestinal Microbiome Composition. The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.

    Time frame: 3-5 years post RYGB

Secondary outcomes

  1. Plasma levels of cholic acid, chenodeoxy cholic acids, deoxycholic acid, and lithocholic acid will be measured by LCMS and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.

    Time frame: 3-5 years post RYGB

  2. Plasma levels of GLP-1, GLP-2, and PYY will be measured by ELISA and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.

    Time frame: 3-5 years post RYGB

  3. Plasma levels of Lipopolysaccharide (LPS) will be measured by the Limulus Amebocyte Lysate (LAL) assay and will be compared between successful weight loss and poor weigh loss post-RYGB and control groups.

    Time frame: 3-5 years post RYGB

Sponsors and collaborators

Lead sponsor

North Dakota State University

Other

Registry information

Official study title

The Gut Microbiota in Patients Post Roux-en-Y Gastric Bypass Surgery

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2016
Registry last updated
Aug 23, 2018

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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