Diets in Symptom Relief & the Influence of Quality of Life in People With

Status Completed

Clinical Trial Summary

Subjects with confirmed diagnosis of Irritable Bowel Syndrome will be blinded and randomly assigned to one of two groups, the low FODMAP diet or the conventional IBS diet group. They will be referred to do three hydrogen breath tests prior to diet education. Upon completion, subjects will attend dietitian consultations at Week 0, 6 and 10 for diet assessment, education and reinforcement. At Week 4 and 8, dietitians will telephone patients to check on diet compliance and answer any diet question. Two sets of questionnaires, the IBS Global Improvement Scale and the IBSQOL will be given to patients to complete before each dietitian visit at week 0, 6 and 10. Two sample t-test and Chi square test will be used to test the difference between the two groups and the association between breath tests results and responds to the two diets.

Clinical Trial Description

1. Subjects who are interested will be interviewed and screened for IBS with Rome Ⅲ criteria by the principle investigator. Research information will be explained in length and consent form will be signed if they agreed to participate

2. Subjects will be blinded and randomly assigned to Conventional IBS diet group (A) or Low FODMAP diet group (B)

3. 3 Breath tests (lactulose, fructose, lactose) will be carried out for all subjects before diet education

4. Subjects will be asked to come to the dietitians clinic and receive the first one hour diet education (including diet assessment & diet education) and two times thirty minutes follow-up appointments with the dietitians at Week 0, 6 and 10, respectively

5. Subjects will be asked to record their food intake and signs and symptoms onto a food record book

6. Subjects will be asked to fill out the IBS Global Improvement Scale and the IBSQOL questionnaire at Week 0, 6 & 10

7. At week 4 and week 8, telephone interviews will be conducted by the dietitians to reinforce diets and answer diet questions

8. Results of IBS Global Improvement Scale and IBSQOL questionnaire will be analyzed using two sample t-test to test the difference between control and treatment group

9. Chi square test will be used to look at the association between breath tests results and responds to the two diets ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02450370
Study type	Interventional
Source	Hong Kong Sanatorium & Hospital
Contact
Status	Completed
Phase	N/A
Start date	May 2015
Completion date	November 20, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Diets in Symptom Relief and the Influence of Quality of Life in People With Irritable Bowel Syndrome

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms