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NCT07277465: MICROOBAR

Role of the Microbiota in Obesity: Effect After Bariatric Surgery

Completed NA Last updated 18 December 2025
What this trial tests

NA trial testing Bariatric surgery in Obese Patients With Bariatric Surgery in 60 participants. Completed in 31 May 2025.

Timeline
3 March 2021
Primary endpoint
31 January 2025
31 May 2025

Quick facts

Lead sponsorCelia Bañuls
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment60
Start date3 March 2021
Primary completion31 January 2025
Estimated completion31 May 2025
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Celia Bañuls — full company profile →

Who can join

Adults 18 to 65, any sex, with Obese Patients With Bariatric Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Several studies have demonstrated that bariatric surgery is effective for inducing weight loss in obese patients. In addition, the effects of this surgery on multiple associated alterations are well known, including changes in the secretion and activity of hormones involved in appetite regulation, satiety, and energy expenditure, as well as alterations in the gut microbiota composition. However, in cases of severe obesity, recent data have challenged the prevailing view, as bacterial species associated with low microbial richness (prior to surgery) appear to change only marginally after bariatric surgery, despite significant metabolic improvements. Our objective is to examine whether gut microbiota and gastrointestinal peptides are further impaired in severe obesity and, additionally, to explore how the microbiota relates to metabolic profile or sex, as well as whether bariatric surgery may differentially correct obesity-related intestinal microbial features. To this end, we propose a prospective, interventional, translational clinical study involving a cohort of 60 obese patients (BMI \> 35 kg/m²) undergoing laparoscopic gastric bypass surgery. Patients will be grouped according to their degree of obesity to assess potential baseline differences and to evaluate the efficacy of the intervention. Furthermore, we will investigate whether these parameters differ according to metabolic profile or sex. Body composition and nutritional status will be assessed, along with cardiovascular risk factors and comorbidities (hypertension, obstructive sleep apnea syndrome, dyslipidemia, type 2 diabetes mellitus, and insulin resistance). Gastrointestinal hormones (ghrelin, GIP, GLP-1, PYY, CCK, and leptin) will be measured in serum using Luminex XMAP technology. The content and diversity of the gut microbiota will be analyzed (16S rRNA amplicon sequencing and shotgun metagenomic sequencing using Illumina MiSeq technology) in stool samples collected before and 6-12 months after surgery. Additionally, individualized dietary follow-up and assessment of participants' quality of life will be conducted.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Bariatric surgery

Trials testing the same drug.

Other recruiting trials for Obese Patients With Bariatric Surgery

Currently open trials in the same condition.

Other Celia Bañuls trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing