Consumption of ancient grain flours as a new therapeutic option for irritable bowel syndrome
| ISRCTN | ISRCTN12170245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12170245 |
| Secondary identifying numbers | 279/2022/CE |
- Submission date
- 24/04/2025
- Registration date
- 13/06/2025
- Last edited
- 13/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Climate change and its impact on food systems have renewed interest in sustainable crops like ancient grains, which offer environmental and nutritional benefits. Unlike modern cereals, ancient grains are less processed, more resilient to harsh conditions, and have a lower environmental footprint. Emerging evidence suggests that certain ancient grains, such as Triticum monococcum and Jermano wheat, may be better tolerated in individuals with irritable bowel syndrome (IBS) due to their lower fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) content and improved digestibility. This study investigates the potential of these grains in developing a functional pasta to manage IBS symptoms.
Who can participate?
Adult patients aged 18 years and over with a diagnosis of IBS
What does the study involve?
Participants are randomly allocated to the intervention group or the control group. The intervention group receives a low-FODMAP diet that includes the functional pasta (80 g, 4 times per week) for 4 weeks. The control group receive a low-FODMAP diet that includes gluten-free pasta (80 g, 4 times per week) for 4 weeks. Gastrointestinal symptoms, mood disturbances and quality of life will be assessed using validated clinical questionnaires at the start and the end of the study.
What are the possible benefits and risks of participating?
The potential benefit is an improvement in IBS symptoms. There are no risks for participants.
Where is the study run from?
University Magna Grecia (Italy)
When is the study starting and how long is it expected to run for?
Septemper 2022 to Septemper 2024
Who is funding the study?
University Magna Grecia (Italy)
Who is the main contact?
Prof. Tiziana Montalcini, tmontalcini@unicz.it
Contact information
Public, Scientific, Principal Investigator
Magna Graecia University
Viale Europa
Catanzaro
88100
Italy
 ORCID ID |
0000-0001-7048-5830 |
|---|---|
| Phone | +39 9613697314 |
| tmontalcini@unicz.it |
Study information
| Study design | Randomized open-label clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | 47228_PIS_V1.0_05Sept2022.pdf |
| Scientific title | Ancient grain flours in IBS |
| Study acronym | AGORA-IBS |
| Study objectives | The hypothesis is that the consumption of a functional pasta made from ancient grains will result in a significant reduction in symptom severity in patients with irritable bowel syndrome (IBS). |
| Ethics approval(s) |
Approved 15/09/2022, Ethics Committee Calabria Region Central Area Section (Comitato Etico Regione Calabria Sezione Area Centro) (A.O.U. Mater Domini in Via Tommaso Campanella, 115, Catanzaro, 88100, Italy; +39 (0)961 712 111; comitatoetico@hotmail.it), ref: 279/2022/CE |
| Health condition(s) or problem(s) studied | Irritable bowel syndrome |
| Intervention | Participants will be enrolled after providing written informed consent and will be randomly assigned (by computer-generated random numbers) in a 1:1 ratio to one of two treatment groups: Group 1: Patients following a low-FODMAP diet including the functional pasta (80 g, 4 times per week). Group 2: Patients following a low-FODMAP diet including gluten-free pasta (80 g, 4 times per week). Participants will be assessed using validated clinical questionnaires evaluating gastrointestinal symptoms. |
| Intervention type | Supplement |
| Primary outcome measure | Gastrointestinal symptoms measured using the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) at baseline and after 4 weeks of treatment |
| Secondary outcome measures | The following secondary outcome measures are assessed at baseline and after 4 weeks of treatment: 1. Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) 2. Quality of life measured using the SF-36 scale (IQOLA SF-36 Italian version 1.6) |
| Overall study start date | 15/09/2022 |
| Completion date | 17/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 42 |
| Key inclusion criteria | 1. Age ≥ 18 years 2. Diagnosis of irritable bowel syndrome (IBS) |
| Key exclusion criteria | 1. Confirmed diagnosis of celiac disease or wheat allergy 2. Organic gastrointestinal disorders 3. Severe systemic conditions 4. Malnutrition 5. Psychiatric disorders 6. Adherence to specific dietary regimes 7. Pregnant or breastfeeding women |
| Date of first enrolment | 17/03/2023 |
| Date of final enrolment | 26/07/2024 |
Locations
Countries of recruitment
- Italy
Study participating centre
Campus Universitario S. Venuta
Catanzaro
88100
Italy
Sponsor information
University/education
Viale Europa
Catanzaro
88100
Italy
| Phone | +39 0961 3694001 |
|---|---|
| protocollo@cert.unicz.it | |
| Website | https://web.unicz.it |
"ROR" |
https://ror.org/0530bdk91 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/11/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in a journal in English with an impact factor, and in the mass media. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof Tiziana Montalcini, tmontalcini@unicz.it. The IPD that underlie the results reported in the main publication (including baseline data, primary outcomes, and secondary outcomes) will be made available after de-identification. The data will be accessible beginning 6 months after publication and for up to 5 years by researchers who provide a methodologically sound proposal. Data will be shared in accordance with participant consent and applicable ethical guidelines. A data-sharing agreement may be required. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 05/09/2022 | 29/04/2025 | No | Yes |
Additional files
Editorial Notes
29/04/2025: Study's existence confirmed by the Ethics Committee Calabria Region Central Area Section (Comitato Etico Regione Calabria Sezione Area Centro).
