Comparative measurements of Intestinal permeability by using urine Lactulose/Mannitol ratio between patient with Functional bloating or bloating predominant FGIDs, Inflammatory bowel disease (IBD) and healthy volunteer

Not Applicable

• Conditions: Intestinal permeabilityGastrointestinal symptoms; Intestinal permeability; Urine Lactulose and Mannitol ratio; Bloating; Crohn’s disease

• Registration Number: TCTR20200203001
• Lead Sponsor: Siriraj Medical Research Ceter (SiMR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-12-31
• Study Start: 2020-02-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1 Age 18-65 year
2 Population group
2.1 Healthy
Or
2.2 Patient with Functional bloating or Functional gastro-intestinal disorder From Rome IV criteria
Or
2.3 Patient with small bowel Crohn’s disease with disease activity from CDAI >= 220

Exclusion Criteria

1 Previous bowel resection
2 Uncontrolled underlying diseases
3 Active smoking or drinking
4 Using medications included NSIADs, antispasmodic and prokinetics agents within 2 weeks prior to study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal permeability 2, 4 and 6 hours after ingestion ratio of percentage excretion of lactulose and mannitol in urine (uLMR)

Secondary Outcome Measures

Name	Time	Method
Symptoms and Quality of life Before and after Modified GIS rating scale and GIQoL ,Safety and tolerability After Symptoms