An interventional study of moderate intensity continuous training in Irritable Bowel Syndrome, Obesity and Dysbiosis, sponsored by Cairo University. Completed at 2 sites in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Cairo University · Not applicable, Interventional, and Supportive care
investigating the response of gut bacteria via measuring short chain fatty acids and Glucagon like peptide hormone to two different modes of exercises in pre-diabetic, obese patients with irritable bowel syndrome. It will be hypothesized that there will be no significant difference between the moderate continuous versus high interval intensity training on gut dysbiosis and glucagon like peptide hormone in irritable bowel syndrome.
The human gastrointestinal tract represents one of the largest organ between the host, environmental factors and antigens in the human body. In an average life time, around 60 tonnes of food pass through the human GI tract, along with an abundance of microorganisms from the environment which impose a huge threat on gut integrity. The collection of bacteria, archaea and eukarya colonising the GI tract is termed the 'gut microbiota' and has co-evolved with the host over thousands of years to form an intricate and mutually beneficial relationship.The gut microbiota enjoys a mutualistic relationship with the host, harvesting additional energy and nutrients from the diet and protecting the host from pathogens. The resident bacteria produce a wide range of metabolites and chemicals that influence host function and these include short-chain fatty acids such as butyrate, which is essential for the integrity of the colonic epithelium.
However, there is potential for these mechanisms to be disrupted as a result of an altered microbial composition, known as dysbiosis. Human Gut dysbiosis is linked to many pathologic conditions disturbing the energy metabolism; such as obesity and atherosclerosis. The microbiota in the human gut is mostly composed of bacterial phyla: Firmicutes and Bacteroidetes. Firmicutes bacteria are Gram-positive one. It plays a key role in the nutrition and metabolism of the host through SCFA synthesis. Through their metabolic products, Firmicutes bacteria are indirectly connected with other tissues and organs and regulate hunger and satiety. In contrast, Bacteroidetes bacteria are Gram negative and associated with immunomodulation. Increased or decreased Firmicutes / Bacteroidetes (F/B) ratio are associated with the development of obesity or irritable bowel disease (IBD). Short-chain fatty acids (SCFAs), the primary metabolite for colonocytes, are produced in the intestinal lumen by commensal anaerobic bacteria via carbohydrate fermentation. they play a role in preserving gut barrier functions, and have immunomodulatory and anti-inflammatory properties also it regulates the synthesis of the hunger-suppressing hormones leptin, peptide YY, and glucagon- like peptide 1. The gut microbiota can also affect appetite and satiety via vagus nerve activation or immune-neuroendocrine mechanisms. Irritable bowel syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and changes in bowel habits without any known organic causes. Fecal SCFAs abnormalities have been reported in patients with IBS, implying that alterations in SCFAs might be related to IBS. The cause of IBS remains unknown, and no single treatment is found to be universally applicable to all patients with IBS. Among humans, positive correlations were reported between bacterial diversity, butyrate-producing bacteria and cardiorespiratory fitness (VO2max), and higher turnover of carbohydrates and proteins, and concentrations of short-chain fatty acids in athletes compared to sedentary controls. There is also growing evidence that physical activity status and exercise training may shape the gut microbiome.
Physical activity stimulates bacterial community richness by altering SCFAs-producing species, as well as favoring the colonization of health and athletic performance-promoting strains. The ability to promote a bacterial composition capable of protecting the intestinal mucosa also it was found that the effects on gut microbiome seem to gradually disappear when the physical activity is no longer practiced. Moderate aerobic exercise affects the intestinal system mainly through gut immune function gut barrier integrity through tight junction proteins expression and IgA production hypothalamic-pituitary-adrenal (HPA) axis stimulation which, in turn, affects enteric nervous system and intestinal transit time, as well as gut motility, intestinal pH and gut hormones release and bile acids metabolism within enterohepatic circulation. High intensity interval training (HIIT) encompasses exercise prescriptions that are tailored to individual needs and can be used in most any exercise setting. This ability to adapt makes HIIT a valuable tool in the exercise programming of patients with a chronic disease. HIIT has a positive effect on the Bacteroidetes/Firmicutes ratio and also increased the alpha diversity in gut microbiota.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 66 is close to the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
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Exclusion Criteria:
Patients will receive moderate intensity continuous training The program will be in form of Frequency Moderate continues training will be scheduled 3 times per week for 12 weeks Intensity 65-75% of target heart rate. Duration 40 minutes per session.
Other: moderate intensity continuous training
Patients will receive high intensity interval training. The program will be in form of Frequency: High intensity interval training will be scheduled 3 times per week for 12 week Intensity 90% of target heart rate including 10 bouts of 1 minute interspersed with 10 bouts of 1 minute of active recovery 50% of target heart rate. Duration the session will last 30 minutes includes warming up and cooling down periods.
Other: moderate intensity continuous training
Patients will be instructed to follow low fermentable short chain carbohydrates diet (low FODMAP) intervention for 12 weeks limiting daily fermented carbohydrate and dairy products and increase intake of protein, whole grains, fruits and vegetables
Other: moderate intensity continuous training
exercise and diet
Also known as: high intensity interval training, low fermentable short chain carbohydrates diet (low FODMAP)
Short Chain fatty acids
fecal sample will be separated. Applying four analytes, including total SCFAs, acetate, propionate, and butyrate, will be targeted. Final concentrations will be calculated based on internal standards and are expressed as micromoles per gram of wet feces (μmol/g). Techniques and predictive approaches will be used across. gas chromatography will be used to quantify Short Chain Fatty Acids (SCFAs) from fecal samples
Time frame: before the start of the trial and at the end of the trial 3 months
Glucagon like peptide hormone
Glucagon like peptide hormone will be measure with Elisa Kit an Enzyme-Linked Immunosorbent Assay. The plate will be pre-coated with Human GLP-1 antibody
Time frame: before the start of the trial and at the end of the trial 3 months
Body Mass Index
weight and height will be recorded to calculate body mass index (BMI) according to the following equation BMI= weight/height2 (Kg/m2)
Time frame: before the start of the trial and at the end of the trial 3 months
irritable bowel syndrome severity scoring system
This five-item questionnaire will measure IBS symptom severity by addressing abdominal pain (frequency and severity), bloating, dissatisfaction with bowel habits, and interference with daily activities. Each question score ranges from 0 to 100 and a higher score indicates more severe GI symptoms. A total score of 75-175 represents mild IBS, 176-300 moderate IBS and \>300 severe IBS
Time frame: before the start of the trial and at the end of the trial 3 months
rritable bowel syndrome quality of life questionnaire
The IBS-QoL is a condition-specific instrument will be used to assess the impact of IBS and effects of treatment. It consists of 34 questions which cover eight domains including dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationships. Each item has a five-point response scale (not at all, slightly, moderately, quite a bit, extremely). The responses are summed and averaged for a total score and transformed to a scale between 0 and 100: higher scores indicating better IBS-specific QoL
Time frame: before the start of the trial and at the end of the trial 3 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — study protocol and final results
Supporting information: Study protocol, Icf
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Cairo University