University of Nottingham
Nottingham, NG7 2UH, United Kingdom
NCT Number: NCT06770907
Irritable bowel syndrome (IBS) affects one in seven people with gastrointestinal (GI) symptoms that are detected without an established underlying organic cause. IBS strongly impacts quality of life, is a leading cause of work absenteeism, and consumes 0.5% of the healthcare annual budget. It manifests in women more than men with symptoms including abdominal pain, bloating, constipation (IBS-C), diarrhoea (IBS-D), and mixed presentations (IBS-M). The development of therapeutic options is hampered by the heterogeneity of IBS, the lack of specificity of its symptom-based definitions, and the poor understanding of the underlying pathophysiological mechanisms.
Many people with IBS find that certain foods (particularly carbohydrates) trigger their symptoms and avoiding such foods has been shown to be effective in IBS. An example of such a diet is the low-FODMAP (fermentable oligo-, di-, monosaccharides and polyols) exclusion diet, developed by researchers at Monash University. This has suggested that the food-symptom relation may involve malabsorption of carbohydrates due to inefficient enzymatic breakdown of polysaccharides. However, only a percentage of subjects respond to this diet. Overall, the current findings relating to SI, suggest a strong potential for effective personalized therapeutic (dietary) interventions in subgroups of IBS subjects and suggest similar mechanisms should be investigated in relation to other genes involved in the digestion and absorption of carbohydrates (CDGs). This project aims to understand what the mechanisms for GI symptoms in subjects with these genetic alterations are. Aim of the study is to assess the gut response to a sucrose challenge in single-and double-carriers of the common hypomorphic sucrase-isomaltase variant p. (Val15Phe) vs non- carriers (negative controls) and CSID subjects (positive controls), applying an MRI multiparametric test combined with a breath test.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Nottingham, NG7 2UH, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for CSID subjects:
Exclusion criteria
for CSID subjects:
Inclusion criteria
for healthy participants:
Exclusion criteria
for healthy participants:
Blood, stool and saliva collection
Questionnaire on:
MRI scans and breath test samples collected after drink test with sucrose
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Area under curve (AUC) of the change from baseline for the MRI measured small bowel water content after the drink test with sucrose
Time frame: during 4 days before the MRI study
subject will report food eaten at each meal
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
MRI measured colon free water content, (in arbitrary units) after the drink test
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
small bowel and colon gas content (in arbitrary units) after the drink test
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
small bowel and colon volume in arbritary units after drink test
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
oro-caecal transit time (OCTT), (in arbitrary units) after the drink test
Time frame: baseline and then 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Time frame: time 0
CNAQ questionnaires results
Time frame: time 0
scale measuring the score of anxiety and depression
Time frame: Time 0
Scale measuring the psychosomatic score
Time frame: Up to 3 days before the MRI study
Analysis of of microbiota taxonomic in the two stool samples collected by patient during the day before the MRI study day
Time frame: Up to three days before the MRI study day
Analysis of alfa and beta diversity of microbiota in the two stool samples collected by patient before the study day
Time frame: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Serum levels
Time frame: Baseline and then 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Time frame: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Serum levels
Time frame: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Serum levels
Time frame: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Serum levels
Time frame: at time 0
patients will respond to the below questions:
Why do you try to avoid this food or drink partially or completely (including if you have been told to avoid it by a health care professional such as a doctor or dietitian)
Time frame: at time 0
The LFPQ consists of two tasks requiring different interaction from the participant. One task requires an explicit evaluation of each food item using visual analogue scales. The other requires a quick choice to be made between paired combinations of foods. The order of task completion is randomised.
Time frame: at time 0
participants respond to 14 questions about sugary food and they will respond with a scale from 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree.
Contact information is provided by the study sponsor or research team.
University of Nottingham
Other
Genetic Carbohydrate Maldigestion As a Model to Study Food Hypersensitivity Mechanism and Guide Personalised Treatment Using a Non-invasive Multiparametric Test (WORK PACKAGE 2)
Acronym: GenMalCarb2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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