The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population

NCT ID: NCT01286597

Last Updated: 2012-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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

Conditions

Lactose Intolerance; Irritable Bowel Syndrome

Keywords

lactose intolerance; DNA sequencing; psychosocial factors; irritable bowel syndrome; visceral hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

dietary

Group Type: EXPERIMENTAL

dietary restriction

Intervention Type: DIETARY_SUPPLEMENT

restrict intake of lactose

Interventions

dietary restriction

restrict intake of lactose

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

exclusion diet；food restriction；dietary treatment

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

DAI Ning

Director of Gastroenterology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ning DAI, MD

Role: STUDY_CHAIR

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China

Locations

Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ning DAI, MD

Role: CONTACT

Phone: 0086-13867457664

Email: dainingcn@gmail.com

Facility Contacts

Ning Dai, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 38752653 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26140004 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24308871 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23246646 (View on PubMed)

Other Identifiers

120100047

Identifier Type: -

Identifier Source: org_study_id