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Effect of intragastric balloon on brain-gut-microbiome axis

Regulation of intragastric balloon on appetite and mechanism of brain function

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051878
Enrollment
Unknown
Registered
2021-10-09
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Obesity

Interventions

Experimental group:Intragastric balloon

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years, gender is not limited; 2. BMI 27.5-40 kg/m^2; 3. Those who have tried other weight loss methods in the past but are not satisfied with the effect; 4. Willing to comply with research requirements, including willingness to avoid the use of drugs or other substances for weight loss during the follow-up study; 5. Right-handed, avoid the use of antibiotics and probiotics within 1 month before enrollment; 6. Be able to take proton pump inhibitors and antiemetics as prescribed by the investigator; 7. Can walk completely independently without any serious chronic orthopedic diseases; 8. Willingness to avoid the use of non-steroidal anti-inflammatory drugs during the study period, including aspirin, diclofenac, ibuprofen, naproxen or other known gastric irritating drugs; 9. Willing to accept gastroscopy.

Exclusion criteria

Exclusion criteria: 1. Patients with past or current diagnosis of ketoacidosis; 2. Symptomatic congestive heart failure, arrhythmia or unstable coronary artery disease; 3. Currently suffering from respiratory diseases such as chronic obstructive pulmonary disease (COPD), pneumonia or lung cancer; 4. Received bariatric surgery before enrolling in the study, or may undergo bariatric surgery during the study; 5. Have used intragastric medical devices to lose weight before entering the study; 6. Suffered from acute or chronic pancreatitis within 12 months before entering the study; 7. Past or current history of small bowel obstruction.

Design outcomes

Primary

MeasureTime frame
Body Mass Index;

Countries

China

Contacts

Public ContactZhu Shaihong, Wang Guohui

The Third Xiangya Hospital of Central South University

wangguohui313@vip.163.com+86 15974267868

Outcome results

None listed

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