Clinical trial NCT01286597: The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population
Official title: The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lactose Intolerance
Irritable Bowel Syndrome
Keywords: lactose intolerance
DNA sequencing
psychosocial factors
irritable bowel syndrome
visceral hypersensitivity
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
First posted: 2011-01-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Aged at least 16 years old and not more than 75 years old.
2. Ability to communicate with the investigator, complete study questionnaires (with help of investigator) and provide informed consent.

Exclusion Criteria:

1. Progressive, severe disease requiring active medical management (e.g. advanced cardiac, liver, renal or neurological disease, advanced cancer)
2. History of significant gastrointestinal pathology (other than gastro-oesophageal reflux disease and functional bowel diseases)
3. History of gastro-intestinal surgery (except appendicectomy, cholecystectomy, hernia repair).
4. Evidence of active drug or alcohol abuse

Primary outcomes:
measure: To assess the effects of lactose intolerance on gastrointestinal function and symptoms
timeFrame: Three years
Secondary outcomes:
measure: To measure the intake of dietary lactose in the adult general population and in patients with IBS
timeFrame: three years
measure: To assess genetic factors, tolerance to lactose challenge and visceral sensitivity.
timeFrame: three years
measure: To assess appropriate dosage of lactose hydrogen breath test
timeFrame: two years
measure: To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS.
timeFrame: three years
measure: To explore the association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS patients
timeFrame: two years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China
name: Ning DAI, MD
role: STUDY_CHAIR
References:
citation: Yang 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.
citation: Yang 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.
citation: Yang 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.