At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- methylcellulose (supplement), inulin (supplement), maltodextrin (supplement)
- How long the study runs
- Study runs about 9 months (dates as stated)
- About the drug or intervention
- methylcellulose — supplement: 2.5 and 5 gm Methylcelllose heated to create a gel · inulin — supplement: 2.5 and 5 gm inulin powder dissolved in water · maltodextrin — supplement: 2.5 and 5gm maltodextrin dissolved in water
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 35
- Started
- 2024-09-30
- Last checked
- 2024-11
Plain English Summary
What is this study?
- • Testing a new treatment for irritable bowel syndrome
- • NA - 35 participants
- • To determine the effect on tolerance and gas production from chronic feeding of fermentable fibre (inulin) incorporated into a gel forming fibre (methylcellulose) compared with placebo (maltodextrin)
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with irritable bowel syndrome
Where?
- • Nottingham - Nottingham Digestive Disease Centre
- • Nottingham - Nottingham Digestive Diseases Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
To determine the effect on tolerance and gas production from chronic feeding of fermentable fibre (inulin) incorporated into a gel forming fibre (methylcellulose) compared with placebo (maltodextrin)
More detail
Our challenge is to understand how various dietary fibres interact to alter colonic fermentation of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) with the aim of reducing gaseous distension of the colon and hence symptoms. Our previous studies have shown how psyllium, a gel forming natural fibre can reduce gas production induced by a dietary FODMAP inulin when it reaches the colon. The investigators are exploiting a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances 2. The investigators have completed a study using a modified methylcellulose which was shown to be non-inferior to psyllium. Our previous studies point to the importance of habitual FODMAP intake which is likely to alter the microbiota, selecting those that can efficiently utilise fructans. The investigators want to understand whether chronic feeding of inulin along with methylcellulose, a gel-forming dietary fibre which persists in the colon, will significantly alter the tolerance to inulin relative to chronic feeding of inulin with a suitable placebo maltodextrin. Maltodextrin is rapidly absorbed in the small bowel and therefore has no effect on colonic fermentation. The investigators plan to run a chronic feeding study in IBS patients and wish to ascertain tolerability of repeated use as previous studies have only provided single doses. With this in mind, the investigators plan to provide inulin and methylcellulose for daily consumption by healthy adults for a period of two weeks. The intervention will be divided into 3 portions to be taken before breakfast, lunch and supper. In week 1, the portions will contain 2.5 g of both inulin and methylcellulose in 62.5 mL water. In week 2, the portions will contain 5.0 g of both inulin and methylcellulose in 125 mL water. The participants will also follow the same chronic feeding schedule but with a maltodextrin placebo as opposed to methylcellulose, with randomisation of study schedule taking place at screening. The investigators will use MRI at baseline and at 2 weeks to assess changes in colonic volume and transit utilising high MRI contrast capsules54. The investigators will collect stool samples at baseline and after 1 and 2 weeks of chronic feeding for each study intervention to monitor the expected changes in microbiota. The primary objective is to assess the fermentation of inulin given as a single 15g with or without methylcellulose from the breath hydrogen response at baseline and after the 2 weeks feeding. .
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
What the study is looking for
- ✓• Aged between 18 and 65 years old.
- ✓Able to give agreement to take part.
- ✓Scoring ≤5 (i.e., mild, or less) for symptoms of flatulence, bloating, abdominal pain, loose stool, and hard stool...
- ✓Agrees to consume the meals provided.
- ✓Agrees to not smoke during the breath hydrogen sampling period.
Who cannot take part
- ✗• Pregnancy, lactating, or planning pregnancy during the course of the investigation declared by candidate.
- ✗History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function.
- ✗Reported history of previous resection of the oesophagus, stomach, or intestine (excluding appendix).
- ✗Intestinal stoma.
- ✗Has a body mass index (BMI) value less than 18.5 or greater than 35.
See the full criteria
Where Is This Study? (2 UK sites)
Nottingham Digestive Disease Centre
Nottingham NG7 2UH, United Kingdom
Nottingham Digestive Diseases Centre
Nottingham NG7 2UH, United Kingdom
How to Get in Touch
Alsion Thorpe, MD
Sponsor contactCONTACT
Sponsor
Sponsor contactCONTACT