Study on the impact of methylcellulose and a special carbohydrate on bowel gas in people with IBS and constipation
| ISRCTN | ISRCTN11466016 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11466016 |
| IRAS number | 349409 |
| Secondary identifying numbers | 25001 |
- Submission date
- 17/03/2025
- Registration date
- 03/04/2025
- Last edited
- 26/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Increasing fibre intake provides numerous health benefits, including reducing obesity, type II diabetes, and colon cancer. However, many individuals with irritable bowel syndrome (IBS) avoid high-fibre foods due to the discomfort and gas they can cause. One particular group of fibres, known as FODMAPs, consists of carbohydrates that humans cannot digest. These carbohydrates pass into the colon, where they are fermented by bacteria, producing gas. Inulin, a common dietary FODMAP found in bread and flour, can cause the colon to swell with gas a few hours after ingestion, which can be measured using MRI. This swelling may lead to symptoms of bloating and abdominal discomfort. Methylcellulose (MC) is an inexpensive food additive, approved as safe, and widely used by the food industry as a thickener and emulsifier. This study aims to determine if adding MC to inulin can reduce the amount of gas accumulating in the colon and, consequently, alleviate IBS symptoms. MC also acts as a mild laxative, softening stool and improving constipation. It is hypothesized that repeated consumption of inulin will, over time, alter the colonic bacteria, enabling them to use inulin more efficiently and produce less gas.
Who can participate?
Adult patients with IBS with constipation
What does the study involve?
To test these hypotheses, this study will compare the effects of MC and a placebo (maltodextrin, a readily absorbed carbohydrate) on colonic gas induced by inulin. The gas will be measured using MRI both before and after three weeks of regular inulin consumption combined with either MC or placebo. Additionally, the study will measure bowel transit time using marker pills visible on MRI scans and assess whether three weeks of inulin consumption will alter the stool microbiota and the breakdown of inulin.
What are the possible benefits and risks of participating?
The study team cannot promise that participation in the study will help, but the information generated from this study may help with future research to develop dietary supplements that would be helpful to people with IBS-C.
MC is a widely used food ingredient and approved as safe to consume.
MRI scans are noisy, and earplugs will be provided.
MRI scans use radio waves and are entirely safe following our standard MRI safety questionnaire.
Participants with tattoos may feel a burning sensation during their scan.
The scans are not intended for diagnostic purposes, so it is unlikely that any abnormalities will be detected. However, if something unusual is found, a radiologist will review the scans, and participants will be asked for their consent to allow the study team to contact their GP.
Inulin may produce gas and bloating with abdominal discomfort. The dose will be adjusted if necessary.
Although all communications are kept confidential, if any information is disclosed that is perceived to put the individual or others at risk, it may be necessary to report this to the appropriate persons.
Where is the study run from?
Sir Peter Mansfield Imaging Centre, University Park Nottingham, UK
When is the study starting and how long is it expected to run for?
September 2024 to July 2025
Who is funding the study?
Medical Research Council
Who is the main contact?
Prof Robin Spiller, robin.spiller@nottingham.ac.uk
Contact information
Scientific, Principal Investigator
Queens Medical Centre
Clifton boulevard
Nottingham
NG72UH
United Kingdom
 ORCID ID |
0000-0001-6371-4500 |
|---|---|
| Phone | +44 (0)7824328319 |
| robin.spiller@nottingham.ac.uk |
Public, Scientific
Sir Peter Mansfield Imaging Centre
University of Nottingham
Nottingham
NG72UH
United Kingdom
| Phone | +44 (0)7783 425411 |
|---|---|
| neele.dellschaft@nottingham.ac.uk |
Study information
| Study design | Single-centre two-way randomized controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet |
| Scientific title | A randomised, placebo-controlled cross-over study of the effect of chronic feeding of methylcellulose and inulin on inulin fermentation in people with IBS-C |
| Study acronym | TEMPO |
| Study hypothesis | 1. Combining inulin and methylcellulose will reduce colonic gas in IBS patients with constipation after ingestion of inulin 2. Chronic feeding of inulin with or without methylcellulose will reduce colonic gas after inulin ingestion |
| Ethics approval(s) |
Approved 21/03/2025, South Central - Berkshire B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8029; berkshireb.rec@hra.nhs.uk), ref: 25/SC/0079 |
| Condition | Irritable bowel syndrome |
| Intervention | Interventions: study participants will be given two food interventions in a randomised order: 1) A firm gel containing inulin and methylcellulose 2) A liquid containing inulin and maltodextrin (placebo). They will be prepared in the food production facility at the University of Nottingham and stored in the fridge at 4°c and then in the participants’ fridges. All interventions will be prepared to the same concentration of inulin and intervention (methylcellulose) or placebo (maltodextrin), which is based on a volume of 375 ml water with either; 1) 15 g inulin + 15 g methylcellulose in a pot providing a final firm texture after heating 2) 15 g inulin + 15 g maltodextrin in a pot for a final drinkable texture This is a single-centre, 2-way, cross-over study in people with IBS and constipation who will receive either inulin plus maltodextrin (placebo) or inulin plus methylcellulose both given at a dose of 5 g three times daily for 3 weeks. MRI assessment will be performed using a 3 Tesla (3T) whole-body MRI system (Philips Achieva) scanner of mechanistic endpoints at baseline and after 3 weeks of the intervention. The two studies are to be separated by a 4-week washout period. |
| Intervention type | Supplement |
| Primary outcome measure | Colonic gas volume measured by magnetic resonance imaging (MRI) at baseline and after 3 weeks |
| Secondary outcome measures | 1. Whole gut transit measured from the position of MRI markers 24 hours post-ingestion 2. Small bowel water measured using MRI, allowing calculation of the AUC 0-6 hours post inulin ingestion 3. Breath hydrogen measured using MRI, allowing calculation of the AUC 0-6 hours post inulin ingestion 4. Faecal microbiota measured using shotgun metagenomic sequencing at baseline and after 1 and 3 weeks |
| Overall study start date | 01/09/2024 |
| Overall study end date | 01/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 22 |
| Participant inclusion criteria | Meet Rome IV criteria for IBS with constipation |
| Participant exclusion criteria | 1. Pregnancy, lactating, or planning pregnancy during the course of the investigation declared by the candidate 2. History declared by the candidate of pre-existing gastrointestinal disorder other than IBS-C that may affect bowel function including but not limited to: 3. Inflammatory Bowel Disease 4. Coeliac Disease 5. Pancreatitis 6. Gallstone disease (biliary colic, cholecystitis; asymptomatic presence of gallstones permitted) 7. Complicated diverticulitis (asymptomatic presence of diverticula permitted) 8. Cancer of the gastrointestinal tract 9. Gastroparesis 10. Other functional gastrointestinal disorders will be permitted as they frequently co-exist with IBS. 11. Reported history of previous resection of the oesophagus, stomach, or intestine (excluding appendix) 12. Intestinal stoma 13. Have contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury 14. Unable to lie flat and relatively still for less than 5 minutes 15. Any medical condition potentially compromising participation in the study e.g., diabetes mellitus, respiratory disease limiting ability to use breath hydrogen analyser, known intolerance to one of the test substances 16. Has a body mass index (BMI) value less than 18.5 or greater than 35 17. Will not agree to follow dietary and lifestyle restrictions required 18. Unable to stop opiate use or planning to change medication which might alter GI motility. 19. Mebeverine, calcium channel antagonists, selective serotonin reuptake inhibitors, low-dose tricyclic antidepressants, antihistamines, and oral contraceptive pills will be recorded in the CRF but will not be an exclusion criteria provided no change in dosage is planned during the study period. 20. Participants who have taken antibiotics or probiotics within the last 4 weeks 21. Poor understanding of the English language 22. Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM |
| Recruitment start date | 01/05/2025 |
| Recruitment end date | 01/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham
NG72UH
United Kingdom
Sponsor information
University/education
University Park
Nottingham
NG72UH
England
United Kingdom
| Phone | +44 (0)1158231090 |
|---|---|
| sponsor@nottingham.ac.uk | |
| Website | https://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Peer reviewed journals and presentation at conferences |
| IPD sharing plan | The datasets generated will be available upon request from Prof Robin Spiller, robin.spiller@nottingham.ac.uk. The consent form includes confirmation for sending anonymised data to other researchers. All data are anonymised. There are no further ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 17/02/2025 | 24/03/2025 | No | No |
Additional files
Editorial Notes
24/03/2025: Study's existence confirmed by Health Research Authority (HRA) (UK).
