Tolerance of artisanal whole‑grain sourdough bread in people who react to conventional bread

Tolerance to an Artisanal Bread in a Population Intolerant of the Conventional Bread and Study of Associated Markers

This test will see if eating artisanal whole‑grain sourdough bread for 15 days reduces digestive symptoms in adults who report intolerance to conventional white bread.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (other)
• Locations: 2 sites (Bobigny and 1 other locations)
• Trial ID: NCT07568223 on ClinicalTrials.gov

What this trial studies

Adults aged 18–65 with normal BMI who report intolerance to conventional bread and do not have celiac disease are enrolled at the Clinical Research Center in Bobigny. After a 15‑day gluten‑free, low‑fructan washout with baseline questionnaires and stool collection, participants undergo a lactulose‑mannitol urine test and provide samples before starting the intervention. They then consume an artisanal whole‑wheat Russello sourdough bread for 15 days while recording food intake, symptoms, and stool samples. Outcomes include changes in GSRS‑IBS, GIQLI, HADS, FSS, biomarkers such as lipopolysaccharide‑binding protein, and measures of intestinal permeability.

Who should consider this trial

Good fit: Adults 18–65 years old with BMI 18–25 who report intolerance to conventional bread, without celiac disease or food allergy, not pregnant or breastfeeding, and able to attend the research center in Bobigny.

Not a fit: People with celiac disease, known wheat allergy, uncontrolled gastrointestinal or systemic disease, pregnancy or breastfeeding, or who fall outside the age or BMI limits are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If it works, some people who currently react to conventional bread might tolerate artisanal whole‑grain sourdough and have fewer digestive symptoms.

How similar studies have performed: Prior small studies and mechanistic work suggest sourdough fermentation and some ancient wheat varieties can reduce fermentable carbohydrates and perceived symptoms in non‑celiac wheat sensitivity, but clinical evidence is limited and mixed.

Eligibility criteria

Inclusion Criteria:

* Normal weight (18 \< BMI \< 25 kg.m-2)
* Male or female
* 18 to 65 years old
* Adults reporting intolerance to "conventional" bread
* Absence of celiac disease
* Affiliated to a social security scheme
* Free, informed and express consent

Exclusion Criteria:

* People under protective supervision: legal guardianship, tutorship or curatorship
* People with eating disorders (anorexia, bulimia, binge eating)
* Any known food allergy
* Women who are pregnant or potentially pregnant (based on a positive urine pregnancy test at inclusion)
* Breastfeeding women
* Alcohol abuse (\>2 drinks/day). At the time of inclusion, the investigator will assess whether the participant exhibits harmful alcohol consumption
* Untreated hypertension, uncontrolled diabetes, or diseases of the digestive tract (excluding functional intestinal disorders), liver, kidneys, or severe heart disease. The investigator will assess the presence of these conditions on standard clinical criteria and the participants' self-reported medical history at the time of inclusion
* Participation in a clinical study in the three months preceding the study
* Absence of express consent

Where this trial is running

Bobigny and 1 other locations

• Centre de Recherche sur Volontaires — Bobigny, France (RECRUITING)
• Centre de Recherche sur Volontaires (CRV) — Bobigny, Île-de-France Region, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Fabien Wuestenberghs

Conditions: Intolerance to "Conventional" Bread, Bread, Wholemeal flour, Ancient wheat, Sourdough, Gluten, FODMAPs, Digestive tolerance