Clinical trial NCT02654496: Gut Microbiota Post Roux-en-Y Gastric Bypass Surgery
Official title: The Gut Microbiota in Patients Post Roux-en-Y Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Gut Microbiota
Weight Regain
Gastric Bypass
Lead sponsor: North Dakota State University
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3-5 years post gastric bypass patients and control subjects

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Intestinal Microbiome Composition. The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.
timeFrame: 3-5 years post RYGB
Secondary outcomes:
measure: 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.
timeFrame: 3-5 years post RYGB
measure: 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.
timeFrame: 3-5 years post RYGB
measure: 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.
timeFrame: 3-5 years post RYGB
Other outcomes:
Locations:
city: Fargo
country: United States
facility: North Dakota State University/Sanford Health
state: North Dakota
Study officials:
affiliation: North Dakota State University
name: Kristine Steffen, PharmD.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
citation: Fouladi F, Brooks AE, Fodor AA, Carroll IM, Bulik-Sullivan EC, Tsilimigras MCB, Sioda M, Steffen KJ. The Role of the Gut Microbiota in Sustained Weight Loss Following Roux-en-Y Gastric Bypass Surgery. Obes Surg. 2019 Apr;29(4):1259-1267. doi: 10.1007/s11695-018-03653-y.