Effect of Omeprazole on Gut Microbiota in Adults With Obesity and GERD

ConditionsObesity & Overweight Gastroesophageal Reflux Disease

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age50-65

SponsorFederal State Budgetary Scientific Institution

About this trial

This randomized, open-label, parallel-group study will evaluate the effect of short-term omeprazole therapy on gut and oral microbiota in adults aged 50-65 years with obesity and symptomatic gastroesophageal reflux disease. Participants will be randomized 1:1 to receive omeprazole 20 mg once daily for 14 days plus standard non-pharmacological recommendations for gastroesophageal reflux disease, or standard non-pharmacological recommendations alone. Clinical and laboratory assessments will be performed at baseline and after 14 days. Stool and saliva samples will be collected to assess gut and oral microbiota, and blood samples will be collected for laboratory biomarkers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 50 to 65 years, inclusive.

Obesity, defined as body mass index (BMI) ≥30 kg/m².

Symptomatic gastroesophageal reflux disease with mild or moderate typical symptoms, including heartburn and/or regurgitation.

For female participants, postmenopausal status, defined as absence of menstruation for at least 12 months without another apparent cause of amenorrhea.

Disqualifiers

Severe or exacerbated GERD, or GERD requiring acid-suppressive therapy or additional diagnostic evaluation.

Use of proton pump inhibitors or histamine H2-receptor antagonists within 8 weeks prior to enrollment.

Use of systemic antibiotics within 3 months prior to enrollment.

Use of probiotic or synbiotic supplements within 8 weeks prior to enrollment.

Trial design

Design model

Parallel

Treatments tested in this trial

Omeprazole
Drug
Omeprazole 20 mg administered orally once daily for 14 days.
Standard Non-pharmacological Recommendations for GERD
Behavioral
Standard non-pharmacological recommendations for gastroesophageal reflux disease management.

Treatment groups

26 Participants

are divided into 2 treatment groups

Group A: Omeprazole Plus Standard Non-pharmacological RecommendationsExperimental treatment 2 interventions

Group B: Standard Non-pharmacological RecommendationsActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in gut microbiota beta diversity

Gut microbiota beta diversity will be assessed using distance-based measures derived from 16S rRNA gene sequencing of stool samples, including Bray-Curtis dissimilarity and phylogenetic UniFrac distances.

Time frame

Baseline and Day 14

Secondary outcomes

Change in Shannon diversity index

Change in gut microbiota alpha diversity assessed using the Shannon diversity index derived from 16S rRNA gene sequencing of stool samples. Higher values indicate greater microbial diversity.

Time frame

Baseline and Day 14

Change in Simpson diversity index

Change in gut microbiota alpha diversity assessed using the Simpson diversity index derived from 16S rRNA gene sequencing of stool samples. Values range from 0 to 1, with higher values indicating greater microbial diversity.

Time frame

Baseline and Day 14

Change in Chao1 richness estimator

Change in gut microbiota richness assessed using the Chao1 richness estimator derived from 16S rRNA gene sequencing of stool samples. Higher values indicate greater estimated microbial richness.

Time frame

Baseline and Day 14

Change in modified Frequency Scale for the Symptoms of GERD total score

Change in the total modified Frequency Scale for the Symptoms of GERD (mFSSG) score from baseline to Day 14. The questionnaire includes 14 items scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating more frequent GERD-related symptoms.

Time frame

Baseline and Day 14

Other outcomes

Change in oral microbiota composition

Changes in oral microbiota composition will be assessed using microbiome analysis of saliva samples, including measures of microbial diversity and taxonomic composition.

Time frame

Baseline and Day 14

Change in serum lipopolysaccharide-binding protein concentration

Change in serum lipopolysaccharide-binding protein (LBP) concentration from baseline to Day 14.

Time frame

Baseline and Day 14

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Federal State Budgetary Scientific Institution

Lead sponsor

Source ClinicalTrials.gov

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