Effects of Wheat Breads on Symptoms of IBS, a Pilot Study (Wheat-IBS)

Oy Karl Fazer Ab

Status: Completed

Conditions: Irritable Bowel Syndrome; Wheat Sensitivity

Treatments: Other: Gluten-free diet; Other: Regular yeast baked toast bread; Other: Sourdough wheat bread

Study type: Interventional

Funder types: Industry

Identifiers

NCT02572908

Wheat-IBS

Details and patient eligibility

About

This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• IBS & subjective sensitivity to wheat

Exclusion criteria

• celiac disease, pregnancy, lactation, IBD, major GI operations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 3 patient groups, including a placebo group

Fermented wheat bread for 7 days

Active Comparator group

Description:

Long sourdough fermentation

Treatment:

Other: Gluten-free diet

Other: Sourdough wheat bread

Yeast baked wheat bread for 7 days

Placebo Comparator group

Description:

Regular toast bread

Treatment:

Other: Regular yeast baked toast bread

Other: Gluten-free diet

Run-in

Other group

Description:

Gluten-free diet for 7 days before entering either bread period

Treatment:

Other: Gluten-free diet