Intest Res.  2016 Oct;14(4):343-350. 10.5217/ir.2016.14.4.343.

Symptomatic improvement with gluten restriction in irritable bowel syndrome: a prospective, randomized, double blinded placebo controlled trial

  • 1Department of Gastroenterology, Topiwala National Medical College & Bai Yamunabai Laxman Nair Ch Hospital, Mumbai, India.


The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms.
We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who fulfilled the Rome III criteria. Patients with celiac disease and wheat allergy were appropriately excluded. The participants were administered a gluten-free diet for 4 weeks and were asked to complete a symptom-based questionnaire to assess their overall symptoms, abdominal pain, bloating, wind, and tiredness on the visual analog scale (0-100) at the baseline and every week thereafter. The participants who showed improvement were randomly assigned to one of two groups to receive either a placebo (gluten-free breads) or gluten (whole cereal breads) as a rechallenge for the next 4 weeks.
In line with the protocol analysis, 60 patients completed the study. The overall symptom score on the visual analog scale was significantly different between the two groups (P<0.05). Moreover, the patients in the gluten intervention group scored significantly higher in terms of abdominal pain, bloating, and tiredness (P<0.05), and their symptoms worsened within 1 week of the rechallenge.
A gluten diet may worsen the symptoms of IBS patients. Therefore, some form of gluten sensitivity other than celiac disease exists in some of them, and patients with IBS may benefit from gluten restrictions.


Controlled clinical trial; Irritable bowel syndrome; Glutens; Non-celiac gluten sensitivity; Diet, gluten-free

MeSH Terms

Abdominal Pain
Celiac Disease
Diet, Gluten-Free
Edible Grain
Irritable Bowel Syndrome*
Prospective Studies*
Tertiary Healthcare
Visual Analog Scale
Wheat Hypersensitivity


  • Fig. 1 Participants recruitment flow chart showing screening failure and withdrawals. GFD, gluten-free diet.

  • Fig. 2 Overall symptom visual analogue scale (VAS) score between gluten and placebo groups at various time points during the study. GFD, gluten-free diet.

  • Fig. 3 Comparison of (A) abdominal pain, (B) bloating, (C) wind, and (D) tiredness visual analogue scale (VAS) scores in the rechallenge period in gluten and placebo groups. GFD, gluten-free diet.


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