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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Lactose Intolerance Irritable Bowel Syndrome 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: dietary Dietary Supplement: dietary restriction
restrict intake of lactose
Other Name: exclusion diet;food restriction;dietary treatment


Outcome Measures

Primary Outcome Measures :
  1. To assess the effects of lactose intolerance on gastrointestinal function and symptoms [ Time Frame: Three years ]

Secondary Outcome Measures :
  1. To measure the intake of dietary lactose in the adult general population and in patients with IBS [ Time Frame: three years ]
  2. To assess genetic factors, tolerance to lactose challenge and visceral sensitivity. [ Time Frame: three years ]
  3. To assess appropriate dosage of lactose hydrogen breath test [ Time Frame: two years ]
  4. To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS. [ Time Frame: three years ]
  5. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

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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


Contacts
Contact: Ning DAI, MD 0086-13867457664 dainingcn@gmail.com

Locations
China, Zhejiang
Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Ning Dai, MD    0086-13867457664    dainingcn@gmail.com   
Sponsors and Collaborators
Sir Run Run Shaw Hospital
University Hospital, Zürich
Investigators
Study Chair: Ning DAI, MD Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DAI Ning, Director of Gastroenterology department, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT01286597     History of Changes
Other Study ID Numbers: 120100047
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by DAI Ning, Sir Run Run Shaw Hospital:
lactose intolerance
DNA sequencing
psychosocial factors
irritable bowel syndrome
visceral hypersensitivity

Additional relevant MeSH terms:
Lactose Intolerance
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases