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Efficacy of a Gluten-Free Diet in Subjects With Irritable Bowel Syndrome-Diarrhea Unaware of Their HLA-DQ2/8 Genotype.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
May 1, 2016
Imran Aziz et al. (6 authors)
Clinical TrialJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine the effects of a gluten-free diet (GFD) on symptom severity and quality of life in patients with irritable bowel syndrome with diarrhea (IBS-D), stratified by HLA-DQ2/8 genotype.

Results Summary

A 6-week GFD significantly reduced IBS symptom severity in 71% of patients, with similar improvements in anxiety, depression, fatigue, and quality of life. HLA-DQ2/8-positive patients showed greater reductions in depression and vitality scores, while HLA-DQ2/8-negative patients had greater improvements in abdominal distention.

Population

41 patients with IBS-D (20 HLA-DQ2/8-positive, 21 HLA-DQ2/8-negative).

Effective Dosage

Not specified (dietitian-led GFD).

Duration

6 weeks (with long-term follow-up at 18 months for responders).

Interactions

None mentioned.

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
a gluten-free diet (GFD)
decrease
IBS Symptom Severity Score
patients with IBS-D
≥50 points
reduced
#1
a gluten-free diet (GFD)
decrease
mean total IBS Symptom Severity Score
patients with IBS-D
from 286 to 131 points
decreased
#2
a gluten-free diet (GFD)
decrease
abdominal distention
HLA-DQ2/8-negative subjects
-
had a greater reduction
#3
a gluten-free diet (GFD)
decrease
hospital anxiety and depression scores
both groups
-
had marked mean improvements
#4
a gluten-free diet (GFD)
decrease
fatigue impact score
both groups
-
had marked mean improvements
#5
a gluten-free diet (GFD)
increase
Short Form-36 results
both groups
-
had marked mean improvements
#6
a gluten-free diet (GFD)
decrease
depression score
HLA-DQ2/8-positive subjects
-
had a greater reduction
#7
a gluten-free diet (GFD)
increase
vitality score
HLA-DQ2/8-positive subjects
-
had a greater increase
#8
a gluten-free diet (GFD)
decrease
symptoms
patients with IBS-D
-
provided sustained benefit
#9
Abstract

BACKGROUND & AIMS: A gluten-containing diet alters bowel barrier function in patients with irritable bowel syndrome with diarrhea (IBS-D), particularly those who are positive for HLA allele DQ2/8. We studied the effects of a gluten-free diet (GFD) in patients with IBS-D who have not previously considered the effects of gluten in their diet and were unaware of their HLA-DQ2/8 genotype. METHODS: We performed a prospective study of 41 patients with IBS-D (20 HLA-DQ2/8-positive and 21 HLA-DQ2/8-negative) at the Royal Hallamshire Hospital in Sheffield, United Kingdom, from September 2012 through July 2015. All subjects were placed on a 6-week GFD following evaluation by a dietician. Subjects completed validated questionnaires at baseline and Week 6 of the GFD. The primary endpoint was mean change in IBS Symptom Severity Score; a 50-point reduction was considered to indicate a clinical response. Secondary endpoints were changes in hospital anxiety and depression score, fatigue impact score, and Short Form-36 results. Clinical responders who chose to continue a GFD after the study period were evaluated on average 18 months later to assess diet durability, symptom scores, and anthropometric and biochemical status. RESULTS: A 6-week GFD reduced IBS Symptom Severity Score by ≥50 points in 29 patients overall (71%). The mean total IBS Symptom Severity Score decreased from 286 before the diet to 131 points after 6 weeks on the diet (P < .001); the reduction was similar in each HLA-DQ group. However, HLA-DQ2/8-negative subjects had a greater reduction in abdominal distention (P = .04). Both groups had marked mean improvements in hospital anxiety and depression scores, fatigue impact score, and Short Form-36 results, although HLA-DQ2/8-positive subjects had a greater reduction in depression score and increase in vitality score than HLA-DQ2/8-negative subjects (P = .02 and P = .03, respectively). Twenty-one of the 29 subjects with a clinical response (72%) planned to continue the GFD long term; 18 months after the study they were still on a GFD, with maintained symptom reductions, and demonstrated similar anthropometric and biochemical features compared with baseline. CONCLUSIONS: A dietitian-led GFD provided sustained benefit to patients with IBS-D. The symptoms that improved differed in magnitude according to HLA-DQ status. Clinical trials.gov no: NCT02528929.

Medical Subject Headings (MeSH)
AdultDiarrheaDiet, Gluten-FreeFemaleGenotypeHLA-DQ AntigensHumansIrritable Bowel SyndromeMaleMiddle AgedProspective StudiesSeverity of Illness IndexSurveys and QuestionnairesTreatment OutcomeUnited Kingdom
Study Links
Quality Scores
SafetyNot Assessed
Efficacy85/10
Quality80/10
Citation Metrics
Total Citations83
Citations/Year9.2
Relative Citation Ratio4.17
NIH Percentile90.7%
Research Impact Scores
APT Score0.95
Weight Score2.06
Normalized Score0.70
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