Evaluation of tolerance and adherence to a low-FODMAP diet with spelt compared to a previous standard low-FODMAP diet without spelt in people with irritable bowel syndrome: a controlled randomised cross-over trial.

Evaluation of tolerance and adherence to a low-FODMAP diet with spelt compared to a previous standard low-FODMAP diet without spelt in people with irritable bowel syndrome: a controlled randomised cross-over trial. - LFD_2022

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00028991

Enrollment

Registered

2022-05-27

Start date

2022-05-23

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low FODMAP diet for patients with irritable bowel syndrome (IBS) K58

Interventions

Group 1: 4 weeks low-FODMAP diet with spelt (LFD + D) without washout phase Group 2: 4 weeks low-FODMAP diet with spelt (LFD + D) without washout phase

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age = 18 years - Patients with irritable bowel syndrome (diagnosis under exclusion of other possible causes, such as lactose intolerance or chronic inflammatory bowel diseases, such as Crohn's disease) or suspicion of RDS or unclear abdominal complaints - No planned holiday < 7 days during the study period (01.05.2022 to 18.09.2022).

Exclusion criteria

Exclusion criteria: - Pregnancy or breastfeeding - Small intestinal obstruction (SIBO) - Tumour diseases (haematological, solid) - Other severe organ diseases - Diagnosed psychiatric illnesses (bipolar disorder, severe depression, etc...) - Treatment/previous treatment for an eating disorder - Cognitive impairment/mental retardation - Nutritionists

Design outcomes

Primary

Measure	Time frame
LFD - D vs. LFD + D: Comparison points Visual Analog Scale from FIS-Q (mean value from 4 queries)	—

Secondary

Measure	Time frame
- Comparison Pre-post delta IBS-QoL - Comparison of pre-post delta DASS-D (depression), DASS-A (anxiety) and DASS-S (stress), additionally LFD - D vs. LFD + D - Correlation of FIS-Q with basal DASS-D, DASS-A and DASS-S; additional comparison of FIS-Q in participants with and without symptoms of anxiety, depression or stress, as well as during the course of the study. - Correlation basal IBS-SS / DASS D/A/S and over time - Group comparison of delta IBS-SSS overall and in participants with and without anxiety, depression, or stress symptoms - Descriptive presentation of the results from the Likert scales, additionally LFD - D vs. LFD + D	—

Measure

Time frame

- Comparison Pre-post delta IBS-QoL - Comparison of pre-post delta DASS-D (depression), DASS-A (anxiety) and DASS-S (stress), additionally LFD - D vs. LFD + D - Correlation of FIS-Q with basal DASS-D, DASS-A and DASS-S; additional comparison of FIS-Q in participants with and without symptoms of anxiety, depression or stress, as well as during the course of the study. - Correlation basal IBS-SS / DASS D/A/S and over time - Group comparison of delta IBS-SSS overall and in participants with and without anxiety, depression, or stress symptoms - Descriptive presentation of the results from the Likert scales, additionally LFD - D vs. LFD + D

—

Countries

Germany

Contacts

Public ContactYvonne Thomas

Hochschule NeubrandenburgUniversity of Applied SciencesStudiengang Diätetik

al21063@hs-nb.de+491758107511

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026