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Longitudinal multi-omics of host–gut microbe dynamics in GERD patients after using different acid-suppressive drugs

Longitudinal multi-omics of host–gut microbe dynamics in GERD patients after using different acid-suppressive drugs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096996
Enrollment
Unknown
Registered
2025-02-10
Start date
2025-02-11
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux disease

Interventions

Experimental group:Receiving 8 weeks of PPIs-esomeprazole-treatment.
Control group:Receiving 8 weeks of H2RAs-famotidine-treatment.

Sponsors

The Seventh Affiliated Hospital Sun Yat-sen University(Shenzhen)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed with GERD and planned to initiate acid-suppressive therapy. 2.Aged 18 years or older; 3.Agreed to participate in the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Used acid-suppressing agents (e.g., PPIs, H2RAs, PCABs), antacids (e.g., aluminum hydroxide, magnesium aluminum carbonate, alginates), gastrointestinal prokinetic agents (e.g., metoclopramide, domperidone, itopride, mosapride), or gastric mucosal protectants (e.g., bismuth potassium citrate, colloidal bismuth pectin, misoprostol, magnesium aluminum carbonate, sucralfate) in the past 3 months. 2.Have a history of Helicobacter pylori eradication in the past 6 months. 3.Have used laxatives, antibiotics, corticosteroids, metformin, probiotics, or prebiotics in the past 3 months. 4.Have a history of serious gastrointestinal or hepatobiliary diseases or surgeries, such as colorectal cancer, inflammatory bowel disease, colon cancer, liver cancer, etc. 5.Have abnormal bowel movement frequency, such as constipation or diarrhea (less than three bowel movements per week or more than three bowel movements per day). 6.Have severe oral diseases or are undergoing oral treatment, including periodontitis or gingivitis. 7.Have a history of severe, progressive, or uncontrolled heart, liver, kidney, or mental disorders. 8.Have a history of cancer or have undergone cancer treatment, such as chemotherapy, radiation therapy, or immunotherapy. 9.Have a history of drug or alcohol abuse. 10.Pregnant, breastfeeding, or planning to become pregnant; 11.Inability to cooperate, such as an inability to understand the informed consent form or unwillingness to provide personal information; 12.Have mental disorders that hinder cooperation. 13.Have participated in other clinical trials in the past 3 months. 14.Currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Gut microbiota;

Secondary

MeasureTime frame
Oral Microbiome;Peripheral immune signatures;Omics analysis (transcriptome, proteome, and metabolome);Liver and fidney function;Glucose and lipid metabolism parameter;

Countries

China

Contacts

Public ContactMan Yang

The Seventh Affiliated Hospital Sun Yat-sen University(Shenzhen)

yangman@sysush.com+86 15818709496

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026