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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Sir Run Run Shaw Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital, Zürich
Information provided by (Responsible Party):
DAI Ning, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier:
NCT01286597
First received: January 18, 2011
Last updated: July 7, 2012
Last verified: July 2012
  Purpose

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 Intervention
Lactose Intolerance
Irritable Bowel Syndrome
Dietary Supplement: dietary restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population

Resource links provided by NLM:


Further study details as provided by Sir Run Run Shaw Hospital:

Primary Outcome Measures:
  • To assess the effects of lactose intolerance on gastrointestinal function and symptoms [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure the intake of dietary lactose in the adult general population and in patients with IBS [ Time Frame: three years ] [ Designated as safety issue: No ]
  • To assess genetic factors, tolerance to lactose challenge and visceral sensitivity. [ Time Frame: three years ] [ Designated as safety issue: No ]
  • To assess appropriate dosage of lactose hydrogen breath test [ Time Frame: two years ] [ Designated as safety issue: No ]
  • To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS. [ Time Frame: three years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dietary Dietary Supplement: dietary restriction
restrict intake of lactose
Other Name: exclusion diet;food restriction;dietary treatment

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

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Sir Run Run Shaw Hospital

Additional 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
Study First Received: January 18, 2011
Last Updated: July 7, 2012
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 19, 2014