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NCT05874726Active, not recruiting

Biological Sample Repository for Gastrointestinal Disorders

Source: ClinicalTrials.gov · Last updated 2 Dec 2025

Brief summary (registry, in English)

The goal of this observational study has the purpose of collecting biological samples from obese patients undergoing evaluation for weight loss by means of medical or endoscopic therapies; and of post bariatric surgery patients presenting with short- and long-term surgical complications. The aim is to enhance the overall understanding of the mechanisms leading to obesity, weight loss, failure to lose weight, and weight regain following treatment. Additional goals are to determine the efficacy of endoscopic and surgical procedures, to identify potential therapeutic targets and disease biomarkers that predict response to therapy.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
31 Mar 2023
Start date
19 Jul 2023
Primary completion date
Jul 2028
Lead sponsor
Pichamol Jirapinyo, MD, MPH
NCT number
NCT05874726

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 19 Jul 2023 to the primary completion date, Jul 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of any medications (prescription or OTC), including herbal or other supplements for treatment of obesity,
  • History of any psychiatric disorders including dementia, active psychosis, severe depression requiring \> 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months,
  • Use of investigational therapy or participation in any other clinical trial within 12 weeks prior to signing the ICF.

Other illness

  • History of gastrointestinal malabsorptive disorders including a known history of celiac disease, and/or chronic pancreatitis,
  • History of any inflammatory disease of the gastrointestinal tract,
  • History of a myocardial infarction or cerebro-vascular accident in the last year, or history of unstable cardiovascular disease,
  • History of known hormonal or genetic cause for obesity,
  • Any condition or major illness that, in the investigator's judgment, places the subject at undue risk of participating in the repository,

Lab values

  • Positive laboratory tests for any of the following pathogens: Hepatitis B virus (HBV); Hepatitis C virus (HCV); Human Immunodeficiency Virus Types 1 and 2 (HIV); Human T-Lymphotropic virus Types I and II (HTLV); Treponema pallidum (syphilis); Clostridium Difficile (C. Diff)

Age

  • Patient is of childbearing age and not practicing effective birth control method, pregnant or lactating
  • History of cancer or life expectancy of \< 2 yrs,

Other

  • Unable to understand the risks, realistic benefits and requirements of the repository,

Who the study is looking for

  • Be older than 18 years of age,
  • Suffer from obesity, defined by BMI≥30 kg/m2 (body mass index: weight in kilograms divided by the square of the height in meters).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.