The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population
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|ClinicalTrials.gov Identifier: NCT01286597|
Recruitment Status : Unknown
Verified July 2012 by DAI Ning, Sir Run Run Shaw Hospital.
Recruitment status was: Recruiting
First Posted : January 31, 2011
Last Update Posted : July 10, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lactose Intolerance Irritable Bowel Syndrome||Dietary Supplement: dietary restriction||Not Applicable|
Study #1: Questionnaire study in general Chinese population (n=2000).
Study #2: Physiologic study in patients attending gastroenterology clinic (n=600) including in subgroups assessment of genetic factors,tolerance to lactose challenge and assessment of visceral sensitivity.
Study #3: Assessment of appropriate dosage of lactose hydrogen breath test in a population with high-prevalence of lactase deficiency.
Study #4: Impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS.
study #5: The association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS patients
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Dietary Supplement: dietary restriction
restrict intake of lactose
Other Name: exclusion diet；food restriction；dietary treatment
- To assess the effects of lactose intolerance on gastrointestinal function and symptoms [ Time Frame: Three years ]
- To measure the intake of dietary lactose in the adult general population and in patients with IBS [ Time Frame: three years ]
- To assess genetic factors, tolerance to lactose challenge and visceral sensitivity. [ Time Frame: three years ]
- To assess appropriate dosage of lactose hydrogen breath test [ Time Frame: two years ]
- To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS. [ Time Frame: three years ]
- To explore the association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS patients [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286597
|Contact: Ning DAI, MDfirstname.lastname@example.org|
|Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China||Recruiting|
|Hangzhou, Zhejiang, China, 310016|
|Contact: Ning Dai, MD 0086-13867457664 email@example.com|
|Study Chair:||Ning DAI, MD||Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China|