The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population
1 other identifier
interventional
3,000
1 country
1
Brief Summary
Lactose is a carbohydrate found in milk,and Lactase Deficiency (LD) is a condition in which the small intestine cannot digest this carbohydrate due to absent or insufficient amounts of lactase.Individuals with LD may be intolerant of lactose in the diet and experience abdominal cramps, bloating and diarrhea; however the response is variable.Some tolerate moderate amounts of lactose without adverse effect,whereas others experience severe symptoms in response to even small doses. These problems may be representative of wider issues regarding individual tolerance to diet containing ubiquitous poorly absorbed, fermentable carbohydrates (such as: fructose, fructans)and be relevant to symptom generated in patients with diarrhea predominant irritable bowel syndrome (D-IBS). This project will investigate the effects of diet,lifestyle stress and psychiatric dietary on the development of functional gastrointestinal symptoms. Lactose will be used to assess tolerance to dietary challenge, a test that is particularly relevant in a Chinese population with a high prevalence of lactase deficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 18, 2011
CompletedFirst Posted
Study publicly available on registry
January 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 10, 2012
July 1, 2012
1.9 years
January 18, 2011
July 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the effects of lactose intolerance on gastrointestinal function and symptoms
Three years
Secondary Outcomes (5)
To measure the intake of dietary lactose in the adult general population and in patients with IBS
three years
To assess genetic factors, tolerance to lactose challenge and visceral sensitivity.
three years
To assess appropriate dosage of lactose hydrogen breath test
two years
To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS.
three years
To explore the association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS patients
two years
Study Arms (1)
dietary
EXPERIMENTALInterventions
restrict intake of lactose
Eligibility Criteria
You may qualify if:
- Aged at least 16 years old and not more than 75 years old.
- Ability to communicate with the investigator, complete study questionnaires (with help of investigator) and provide informed consent.
You may not qualify if:
- Progressive, severe disease requiring active medical management (e.g. advanced cardiac, liver, renal or neurological disease, advanced cancer)
- History of significant gastrointestinal pathology (other than gastro-oesophageal reflux disease and functional bowel diseases)
- History of gastro-intestinal surgery (except appendicectomy, cholecystectomy, hernia repair).
- Evidence of active drug or alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sir Run Run Shaw Hospitallead
- University Hospital, Zürichcollaborator
Study Sites (1)
Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310016, China
Related Publications (4)
Chen B, Du L, Zhang Y, Cen M, Luo L, Xu M, Kim JJ, Dai N. Natural History and Outcomes of Individuals With Functional Bowel Disorder: A 9-year Population-Based Longitudinal Study. Clin Transl Gastroenterol. 2024 Jul 1;15(7):e00715. doi: 10.14309/ctg.0000000000000715.
PMID: 38752653DERIVEDYang JF, Fox M, Chu H, Zheng X, Long YQ, Pohl D, Fried M, Dai N. Four-sample lactose hydrogen breath test for diagnosis of lactose malabsorption in irritable bowel syndrome patients with diarrhea. World J Gastroenterol. 2015 Jun 28;21(24):7563-70. doi: 10.3748/wjg.v21.i24.7563.
PMID: 26140004DERIVEDYang J, Fox M, Cong Y, Chu H, Zheng X, Long Y, Fried M, Dai N. Lactose intolerance in irritable bowel syndrome patients with diarrhoea: the roles of anxiety, activation of the innate mucosal immune system and visceral sensitivity. Aliment Pharmacol Ther. 2014 Feb;39(3):302-11. doi: 10.1111/apt.12582. Epub 2013 Dec 5.
PMID: 24308871DERIVEDYang J, Deng Y, Chu H, Cong Y, Zhao J, Pohl D, Misselwitz B, Fried M, Dai N, Fox M. Prevalence and presentation of lactose intolerance and effects on dairy product intake in healthy subjects and patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2013 Mar;11(3):262-268.e1. doi: 10.1016/j.cgh.2012.11.034. Epub 2012 Dec 13.
PMID: 23246646DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ning DAI, MD
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Gastroenterology department
Study Record Dates
First Submitted
January 18, 2011
First Posted
January 31, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 10, 2012
Record last verified: 2012-07