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

4 mei 2026 bijgewerkt door: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Abbreviations:

  • GSRS-IBS: Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome
  • GIQLI: Gastrointestinal Quality of Life Index
  • HADS: Hospital Anxiety and Depression Scale
  • FSS: Fatigue Severity Scale
  • LBP: Lipopolysaccharide-Binding Protein

Inclusion Visit (visit 0 [V0])

At the inclusion visit (V0) at Avicenne Hospital (Bobigny), participants will receive study instructions and materials. They will have up to 15 days to:

  • Complete questionnaires (modified GSRS-IBS, Bristol Stool Scale, GIQLI, HADS, FSS)
  • Collect a baseline stool sample, stored at -18°C at home until their first hospital visit (V1).

Wash-out phase (Day-15 [D-15] to Day 0 [D0]):

Participants will follow a gluten-free and low-fructan diet for 15 days. During this period:

  • Daily food intake will be recorded in a diary, with meal photos sent to the research team via a dedicated email
  • On D-8, participants will complete the modified GSRS-IBS and Bristol Stool Scale.
  • On D-1, participants will perform a 24-hour urine collection after ingestion of lactulose (10g) and mannitol (10g) in 200 mL water, divided into three containers:
  • First morning urine
  • 0-5 h collection after sugar ingestion (fasting except water)
  • 5-24 h collection Stool will also be collected on D-1 and stored at 4°C until V1.

First investigation day (Day 0 [D0] - V1):

At 9 a.m., participants arrive the Clinical Research Center (at Avicenne Hospital) with their stool and urine samples.

After completing the questionnaires (modified GSRS-IBS, GIQLI, HADS, FSS, and Bristol Stool Scale), a venous catheter will be inserted for blood sampling.

A 10 mL blood sample will be collected before the test meal. Participants will then consume the test meal (105 g of "artisanal" bread with water).

Postprandial blood samples (2 mL each) will be collected every 30 minutes for 3 hours (total blood volume: 22 mL) The modified GSRS-IBS questionnaire will be completed every hour during the postprandial period If a bowel movement occurs during the visit, the stool sample collected at that time may be used to replace the one collected the previous day.

Intervention phase (D1 to D14):

Participants will continue the same gluten-free, low-fructan diet, with the addition of the "artisanal" bread, which will serve as the sole source of gluten source and the main source of fructans.

  • D1: 75 g of bread
  • D2: 100 g of bread
  • D3-14: 125 g of bread daily (≈ 8.5 g gluten, <1.2 g fructans) Bread consumption may be distributed throughout the day. On D8, participants will again complete the modified GSRS-IBS and Bristol Stool Scale.

Second investigation day (D15 - V2):

On D14, participants will repeat the 24-hour urine and stool collection as previously described. On D15, they will return to the research center and undergo the same procedures as V1.

Measurements:

  • Questionnaires: modified GSRS-IBS (gastrointestinal symptoms), GIQLI, HADS, FSS.
  • Blood: LBP (marker of inflammation), zonulin (marker of intestinal permeability), glucose, insulin.
  • Urine: lactulose and mannitol, with calculation of the lactulose/mannitol ratio as a marker of intestinal permeability.
  • Stool: microbial community analysis (microbiota) and fecal calprotectin (marker of inflammation). Baseline stool samples (before wash-out phase) will also be used to inoculate an artificial colon model for later investigation of the effects of bread on the microbiota.

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Frankrijk
    • Île-de-France Region
      • Bobigny, Île-de-France Region, Frankrijk, 93000
        • Nog niet aan het werven
        • Centre de Recherche sur Volontaires (CRV)
        • Contact:
        • Hoofdonderzoeker:
          • Fabien Wuestenberghs

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Artisanal Bread

"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.
Voedingssupplement: Artisanal Bread

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intensity of gastrointestinal symptoms
Tijdsspanne: Scores at Day 0 [D0] and Day 15 [D15]

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]

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intensity of gastrointestinal and extraintestinal symptoms
Tijdsspanne: Scores at Day 0 [D0] and Day 15 [D15]

The intensity of gastrointestinal and extra-intestinal symptoms will be assessed using the total score of the modified version of the GSRS-IBS questionnaire.

Scores obtained before and after the diet including the "artisanal" bread will be compared.

The score is measured on a 7-point Likert scale, ranging from 1 (Not at all) to 7 (Very severely). The questionnaire consists of 28 questions, so total scores can range from 28 to 196, with higher scores indicating more severe gastrointestinal and extra-intestinal symptoms and, therefore, lower tolerance.
Scores at Day 0 [D0] and Day 15 [D15]
Validity of the modified GSRS-IBS
Tijdsspanne: Scores of the two questionnaires at Day [D0] and Day [D15]

Correlations between the scores from the GSRS-IBS and the modified GSRS-IBS used in this study will be analyzed.

The GSRS-IBS score can be obtained from the modified GSRS-IBS questionnaire. This questionnaire consists of 7-point Likert scale ranging from 1 (No discomfort at all) to 7 (Very severe discomfort) for 13 items. The total score therefore ranges from 13 to 91. An increase in this score indicates greater gastrointestinal discomfort and, consequently, lower tolerance.

The modified GSRS-IBS questionnaire comprises 28 items scored on a 7-point Likert scale, ranging from 1 (Not at all) to 7 (Very severely). Thus, the total score of this questionnaire ranges from 28 to 196. An increase in this score indicates greater gastrointestinal symptoms and, consequently, lower tolerance.

These two scores will be compared, and their correlation analyzed.
Scores of the two questionnaires at Day [D0] and Day [D15]
Comparison between volunteers' perceived tolerance of "artisanal" bread and measured tolerance
Tijdsspanne: Scores at Day 0 [D0] and Day 15 [D15]
In addition to the intensity scores calculated for each symptom (the sum of which constitutes an objective total score), participants will give a global subjective assessment of their tolerance to the "artisanal" bread using a scale from 0 (absence of symptoms) to 10 (extremely intense symptoms). The objective and subjective scores will then be compared, and their correlation analyzed.
Scores at Day 0 [D0] and Day 15 [D15]
Clinical profile of response to the "artisanal" bread
Tijdsspanne: These scores are measured at Day 0 [D0], Day 8 [D8] and Day 15 [D15].
Individual symptoms will be grouped into symptom groups (pain, reflux, indigestion, diarrhea and constipation). A score will be calculated for each groupe, and these scores will be compared.
These scores are measured at Day 0 [D0], Day 8 [D8] and Day 15 [D15].
Evaluation of intestinal permeability
Tijdsspanne: Measured on Day D0 [D0] and Day 15 [D15]
Intestinal permeability will be assessed by measuring serum zonulin levels and the urinary lactulose/mannitol ratio.
Measured on Day D0 [D0] and Day 15 [D15]
Evaluation of intestinal inflammation
Tijdsspanne: Serum LBP : measured on Day 0 [D0] and Day D15 [D15] Fecal calprotectin : measured in stool samples collected at Day-1 [D-1] and Day 14 [D14].
Intestinal inflammation will be assessed by measuring serum LBP and faecal calprotectin.
Serum LBP : measured on Day 0 [D0] and Day D15 [D15] Fecal calprotectin : measured in stool samples collected at Day-1 [D-1] and Day 14 [D14].
Microbiota composition
Tijdsspanne: Determined in stool samples collected at visit 0 [V0], on Day -1 [D-1] and Day 14 [D14]

The relative abundance of bacterial genera in stool samples at the end of each diet (with and without bread) will be compared.

Stool samples will also be collected at inclusion (visit 0 [V0]) to determine the baseline microbiota and to inoculate an in vitro artificial colon model.
Determined in stool samples collected at visit 0 [V0], on Day -1 [D-1] and Day 14 [D14]
Tolerance profiles for "artisanal" bread
Tijdsspanne: From the enrollment (visit 0 [V0]) to the end of the study (Day 15 [D15])
Exploration of tolerance profiles to "artisanal" bread without a priori, and their characterization based on clinical data (questionnaires) and biological markers (inflammation, intestinal permeability, and microbiota).
From the enrollment (visit 0 [V0]) to the end of the study (Day 15 [D15])
Postprandial glucose responses measured after consumption of the test meal ("artisanal bread")
Tijdsspanne: Measured at 0; 0.5; 1; 1.5; 2; 2.5 and 3 hours after test meal
Blood glucose levels measured every 30 minutes for 3 hours after the test meal
Measured at 0; 0.5; 1; 1.5; 2; 2.5 and 3 hours after test meal
Postprandial insulin responses measured after consumption of the test meal ("artisanal bread")
Tijdsspanne: Measured at 0; 0.5; 1; 1.5; 2; 2.5 and 3 hours after test meal
Blood insulin levels measured every 30 minutes for 3 hours after the test meal
Measured at 0; 0.5; 1; 1.5; 2; 2.5 and 3 hours after test meal
Substrate oxidation rates
Tijdsspanne: Measured at 0; 0.5; 1.5 and 2.5 hours after test meal
Fat and glucose oxidation assessed by measuring respiratory exchanges using indirect calorimetry
Measured at 0; 0.5; 1.5 and 2.5 hours after test meal
H2 concentrations in exhaled air
Tijdsspanne: Measured at 0; 0.5; 1; 1.5; 2; 2.5 and 3 hours after test meal
H2 concentration in air measured every 30 minutes for 3 hours after test meal
Measured at 0; 0.5; 1; 1.5; 2; 2.5 and 3 hours after test meal

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Medewerkers

UMR 914 PNCA - AgroParisTech, INRA, Université Paris-Saclay

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 januari 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

21 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2026

Eerst geplaatst (Werkelijk)

5 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

4 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TOLERBREAD

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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