Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 53 of 228 for:    yeast

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572908
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Oy Karl Fazer Ab

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Wheat Sensitivity Other: Sourdough wheat bread Other: Regular yeast baked toast bread Other: Gluten-free diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
Study Start Date : August 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: Fermented wheat bread for 7 days
Long sourdough fermentation
Other: Sourdough wheat bread
Other: Gluten-free diet
Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains

Placebo Comparator: Yeast baked wheat bread for 7 days
Regular toast bread
Other: Regular yeast baked toast bread
Other: Gluten-free diet
Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains

Run-in
Gluten-free diet for 7 days before entering either bread period
Other: Gluten-free diet
Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains




Primary Outcome Measures :
  1. Subjective symptoms using visual analog scale (VAS) daily [ Time Frame: 7 days ]
    Self-reports of bloating, dyspepsia, constipation, diarrhoea, abdominal pain, borborygmi, flatulence, heart burn, urgency to defecate, incomplete feeling of defecation, abdominal cramps, tiredness, skin rash, mood, nausea, joint pain, ability to concentrate and loss of appetite on VAS 0-100. Participants fill in VAS questionnaires at the end of each day



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IBS & subjective sensitivity to wheat

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572908


Locations
Layout table for location information
Finland
Aava Medical Centre
Helsinki, Finland, 00100
Sponsors and Collaborators
Oy Karl Fazer Ab

Layout table for additonal information
Responsible Party: Oy Karl Fazer Ab
ClinicalTrials.gov Identifier: NCT02572908     History of Changes
Other Study ID Numbers: Wheat-IBS
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Keywords provided by Oy Karl Fazer Ab:
wheat, IBS, gluten, ATI
Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases