CompletedNot Applicable

Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread

Germany24 participantsStarted 2020-05-15

Plain-language summary

This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes will be considered.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 ≤70 years * Signed declaration of consent * Willingness to adhere to the prescribed diet for the duration of the study * Subjective bread wheat intolerance * No known spelled intolerance * No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy) * No participation in another clinical trial (current or within the past 30 days) * Gluten-containing diet at least 6 weeks before the start of the study Exclusion Criteria: * Taking intestinal therapeutics, antibiotics, immunosuppressants or similar * Pregnancy / lactation * Relevant violations of the nutritional protocol * Occurrence of relevant diseases (possibly individual decision) * Revocation of consent * Accommodation in a clinic or similar facility based on an official or judicial order

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of IBS-SSS Total score

Timeframe: Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)

Trial details

NCT IDNCT04401956

SponsorUniversity of Hohenheim

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-10

View on ClinicalTrials.gov More Non-celiac Gluten Sensitivity trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.