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

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.

Study Overview

• Status: Unknown
• Conditions: Irritable Bowel Syndrome; Lactose Intolerance
• Intervention / Treatment: Dietary supplement: dietary restriction

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

• Study Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Recruiting
      • Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China
      • Contact: Ning Dai, MD; Phone Number: 0086-13867457664; Email: dainingcn@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dietary	Dietary supplement: dietary restriction; restrict intake of lactose; Other Names: exclusion diet；food restriction；dietary treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the effects of lactose intolerance on gastrointestinal function and symptoms	Three years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• Collaborators: University Hospital, Zürich
• Investigators: Study Chair: Ning DAI, MD, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimate): January 31, 2011

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 7, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: irritable bowel syndrome; lactose intolerance; visceral hypersensitivity; DNA sequencing; psychosocial factors
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Malabsorption Syndromes; Irritable Bowel Syndrome; Lactose Intolerance
• Other Study ID Numbers: 120100047