NCT07568223

Brief Summary

The objective of this study is to evaluate the effect of consuming an "artisanal" bread for 15 days on gastrointestinal symptoms in individuals intolerant to "conventional" bread. "Conventional bread" refers to bread made with refined wheat flour (ash = 0.55% of dry matter), containing gluten, and leavened with baker's yeast (Saccharomyces cerevisiae). "Artisanal bread" refers to bread made with whole wheat flour (ash = 1.50% of dry matter) from an ancient durum wheat variety (Russello) and leavened with sourdough.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jan 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

January 21, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

January 28, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

January 21, 2026

Last Update Submit

May 4, 2026

Conditions

Intolerance to "Conventional" Bread

Keywords

BreadWholemeal flourAncient wheatSourdoughGlutenFODMAPsDigestive tolerancePostprandial metabolismInflammationIntestinal permeabilityMicrobiota

Outcome Measures

Primary Outcomes (1)

  • Intensity of gastrointestinal symptoms

    The severity of gastrointestinal symptoms will be assessed using a score from the modified GSRS-IBS questionnaire used in this study. This score consists of 13 questions ranging from 1 (Not at all) to 7 (Very severely) on a Likert scale. Thus, the total score can range from 13 to 91, with higher scores indicating more severe gastrointestinal symptoms and, consequently, lower tolerance. The scores obtained before and after the diet including the "artisanal" bread will be compared.

    Scores at Day 0 [D0] and Day 15 [D15]

Secondary Outcomes (12)

  • Intensity of gastrointestinal and extraintestinal symptoms

    Scores at Day 0 [D0] and Day 15 [D15]

  • Validity of the modified GSRS-IBS

    Scores of the two questionnaires at Day [D0] and Day [D15]

  • Comparison between volunteers' perceived tolerance of "artisanal" bread and measured tolerance

    Scores at Day 0 [D0] and Day 15 [D15]

  • Clinical profile of response to the "artisanal" bread

    These scores are measured at Day 0 [D0], Day 8 [D8] and Day 15 [D15].

  • Evaluation of intestinal permeability

    Measured on Day D0 [D0] and Day 15 [D15]

  • +7 more secondary outcomes

Study Arms (1)

Artisanal Bread

EXPERIMENTAL

"Artisanal" bread is made with wholemeal flour (ash = 1.50% of dry matter) from an ancient durum wheat (Russello variety) and leavened with sourdough. "Artisanal" bread contains 6.8g of gluten and less than 1g of frutans per 100g.

Dietary Supplement: Artisanal Bread

Interventions

Artisanal BreadDIETARY_SUPPLEMENT

During the second part of the study (from Day 1 \[D1\] to Day 14 \[D14\]), participants will consume the "artisanal" bread on a daily basis. Dose: D1 = 75g; D2 = 100g; from D3 to D14: 125g/day On D0 and D15, volunteers will come to the hospital for 3 hours of postprandial testing.

Artisanal Bread

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal weight (18 \< BMI \< 25 kg.m-2)
  • Male or female
  • 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

You may not qualify if:

  • People under protective supervision: legal guardianship, tutorship or curatorship
  • People with eating disorders (anorexia, bulimia, binge eating)
  • Any known food allergy
  • Breastfeeding women
  • Participation in a clinical study in the three months preceding the study
  • Absence of express consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de Recherche sur Volontaires

Bobigny, 93000, France

RECRUITING

Centre de Recherche sur Volontaires (CRV)

Bobigny, Île-de-France Region, 93000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Fabien Wuestenberghs

CONTACT

+330148952276fabien.wuestenberghs@aphp.fr

Claire Gaudichon

CONTACT

+33144081829claire.gaudichon@agroapristech.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

May 5, 2026

Study Start

January 28, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-05

Locations

FR(2)