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

4. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Frankrike
    • Île-de-France Region
      • Bobigny, Île-de-France Region, Frankrike, 93000
        • Har ikke rekruttert ennå
        • Centre de Recherche sur Volontaires (CRV)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Fabien Wuestenberghs

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intensity of gastrointestinal symptoms
Tidsramme: 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]

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intensity of gastrointestinal and extraintestinal symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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")
Tidsramme: 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")
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. januar 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

21. januar 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TOLERBREAD

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Nei

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