Irritable Bowel SyndromeNCT06408610
Moderate Continuous Versus High Interval Intensity Training on Gut Dysbiosis and GLP1 Hormone in IBS
A study testing moderate intensity continuous training in people with Irritable Bowel Syndrome and Obesity, run by Cairo University at 2 sites in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Irritable Bowel Syndrome, Obesity, Dysbiosis
- What is being tested?
- moderate intensity continuous training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2024to 17 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index must be 30-34.9 kg\m
- Clinical diagnosis of irritable bowel syndrome
- Must be Pre-diabetic HbA1c of 5.7 - 6.4.
- Must be sedentary subject
Who cannot join
- Communication disorders
- Gasterointestinal bleeding
- Antibiotics or probiotics in the last 2 months
- Recent surgeries in the last 6 months
- Colorectal cancer or any terminal diseases
- Fibromylgia or Multiple sclerosis
Show all 12Show fewer
- Palpable abdominal mass
- Cardiovascular diseases
- Active smokers
- Musculoskeletal injuries that interfere with exercise program
- Upper respiratory infections
- Uncontrolled hypertension
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of medicine cairo university
Cairo
Faculty of physiotherapy cairo university
Giza
About this study
Official title: Moderate Continuous Versus High Interval Intensity Training on Gut Dysbiosis and Glucagon Like Peptide Hormone in Irritable Bowel Syndrome
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.
Read the detailed description
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.
- Conditions
- Irritable Bowel Syndrome, Obesity, Dysbiosis
- Being tested
- moderate intensity continuous training
- Medical subject headings
- Irritable Bowel Syndrome, Obesity, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate intensity continuous trainingOther
Also called high intensity interval training, low fermentable short chain carbohydrates diet (low FODMAP)
exercise and diet
| Study group | Role | What they receive |
|---|---|---|
| moderate intensity continuous training | Experimental | 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. Receives: Other: moderate intensity continuous training |
| high intensity interval training | Experimental | 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. Receives: Other: moderate intensity continuous training |
| low fermentable short chain carbohydrates diet | Experimental | 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 Receives: Other: moderate intensity continuous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: before the start of the trial and at the end of the trial 3 months
Secondary outcomes (3)
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)
Measured: 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
Measured: 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
Measured: before the start of the trial and at the end of the trial 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 May 2024
- Primary completion15 May 2025
- Study completion17 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Patients will receive moderate intensity continuous training (MICT) 2. Patients will receive high intensity interval training (HIIT) 3. Patients will be instructed to follow low fermentable short chain carbohydrates diet (low FODMAP)
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Saeed Salama, Cairo University
- Investigators
- Donia M Elmasry, Doctorate, Study director, Faculty of physiotherapy Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408610
- Sponsor's protocol ID
- P.T./REC/012/004224
- Status last verified
- Jun 2025
- First submitted
- 7 May 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol and final results
Publications
Aziz I, Simren M. The overlap between irritable bowel syndrome and organic gastrointestinal diseases. Lancet Gastroenterol Hepatol. 2021 Feb;6(2):139-148. doi: 10.1016/S2468-1253(20)30212-0. Epub 2020 Nov 13.
PubMed 33189181Cataldi S, Poli L, Sahin FN, Patti A, Santacroce L, Bianco A, Greco G, Ghinassi B, Di Baldassarre A, Fischetti F. The Effects of Physical Activity on the Gut Microbiota and the Gut-Brain Axis in Preclinical and Human Models: A Narrative Review. Nutrients. 2022 Aug 11;14(16):3293. doi: 10.3390/nu14163293.
PubMed 36014798Cella V, Bimonte VM, Sabato C, Paoli A, Baldari C, Campanella M, Lenzi A, Ferretti E, Migliaccio S. Nutrition and Physical Activity-Induced Changes in Gut Microbiota: Possible Implications for Human Health and Athletic Performance. Foods. 2021 Dec 10;10(12):3075. doi: 10.3390/foods10123075.
PubMed 34945630Chen L, Sun X, Khalsa AS, Bailey MT, Kelleher K, Spees C, Zhu J. Accurate and reliable quantitation of short chain fatty acids from human feces by ultra high-performance liquid chromatography-high resolution mass spectrometry (UPLC-HRMS). J Pharm Biomed Anal. 2021 Jun 5;200:114066. doi: 10.1016/j.jpba.2021.114066. Epub 2021 Apr 6.
PubMed 33866297Clark T, Morey R, Jones MD, Marcos L, Ristov M, Ram A, Hakansson S, Franklin A, McCarthy C, De Carli L, Ward R, Keech A. High-intensity interval training for reducing blood pressure: a randomized trial vs. moderate-intensity continuous training in males with overweight or obesity. Hypertens Res. 2020 May;43(5):396-403. doi: 10.1038/s41440-019-0392-6. Epub 2020 Jan 14.
PubMed 31937915DeGruttola AK, Low D, Mizoguchi A, Mizoguchi E. Current Understanding of Dysbiosis in Disease in Human and Animal Models. Inflamm Bowel Dis. 2016 May;22(5):1137-50. doi: 10.1097/MIB.0000000000000750.
PubMed 27070911Denou E, Marcinko K, Surette MG, Steinberg GR, Schertzer JD. High-intensity exercise training increases the diversity and metabolic capacity of the mouse distal gut microbiota during diet-induced obesity. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E982-93. doi: 10.1152/ajpendo.00537.2015. Epub 2016 Apr 26.
PubMed 27117007Elhosseiny D, Mahmoud NE, Manzour AF. Factors associated with irritable bowel syndrome among medical students at Ain Shams University. J Egypt Public Health Assoc. 2019 Dec 4;94(1):23. doi: 10.1186/s42506-019-0023-8.
PubMed 32813140Gupta AK, Maity C. Efficacy and safety of Bacillus coagulans LBSC in irritable bowel syndrome: A prospective, interventional, randomized, double-blind, placebo-controlled clinical study [CONSORT Compliant]. Medicine (Baltimore). 2021 Jan 22;100(3):e23641. doi: 10.1097/MD.0000000000023641.
PubMed 33545934Koh A, De Vadder F, Kovatcheva-Datchary P, Backhed F. From Dietary Fiber to Host Physiology: Short-Chain Fatty Acids as Key Bacterial Metabolites. Cell. 2016 Jun 2;165(6):1332-1345. doi: 10.1016/j.cell.2016.05.041.
PubMed 27259147Kuhre RE, Wewer Albrechtsen NJ, Hartmann B, Deacon CF, Holst JJ. Measurement of the incretin hormones: glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. J Diabetes Complications. 2015 Apr;29(3):445-50. doi: 10.1016/j.jdiacomp.2014.12.006. Epub 2014 Dec 15.
PubMed 25623632Lin L, Zhang J. Role of intestinal microbiota and metabolites on gut homeostasis and human diseases. BMC Immunol. 2017 Jan 6;18(1):2. doi: 10.1186/s12865-016-0187-3.
PubMed 28061847Mohammed AA, Moustafa HA, Nour-Eldein H, Saudi RA. Association of anxiety-depressive disorders with irritable bowel syndrome among patients attending a rural family practice center: a comparative cross-sectional study. Gen Psychiatr. 2021 Dec 13;34(6):e100553. doi: 10.1136/gpsych-2021-100553. eCollection 2021.
PubMed 34970639Monda V, Villano I, Messina A, Valenzano A, Esposito T, Moscatelli F, Viggiano A, Cibelli G, Chieffi S, Monda M, Messina G. Exercise Modifies the Gut Microbiota with Positive Health Effects. Oxid Med Cell Longev. 2017;2017:3831972. doi: 10.1155/2017/3831972. Epub 2017 Mar 5.
PubMed 28357027Portincasa P, Bonfrate L, Vacca M, De Angelis M, Farella I, Lanza E, Khalil M, Wang DQ, Sperandio M, Di Ciaula A. Gut Microbiota and Short Chain Fatty Acids: Implications in Glucose Homeostasis. Int J Mol Sci. 2022 Jan 20;23(3):1105. doi: 10.3390/ijms23031105.
PubMed 35163038
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Continuous Versus High Interval Intensity Training on Gut Dysbiosis and Glucagon Like Peptide Hormone in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06408610
- Acronym / sponsor ID
- P.T./REC/012/004224
- Conditions
- Irritable Bowel Syndrome, Obesity, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 17 May 2025 (actual)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. Patients will receive moderate intensity continuous training (MICT) 2. Patients will receive high intensity interval training (HIIT) 3. Patients will be instructed to follow low fermentable short chain carbohydrates diet (low FODMAP)
| Arm | Type | Receives |
|---|---|---|
| moderate intensity continuous training | Experimental | Other: moderate intensity continuous trainingPatients 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. |
| high intensity interval training | Experimental | Other: moderate intensity continuous trainingPatients 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. |
| low fermentable short chain carbohydrates diet | Experimental | Other: moderate intensity continuous trainingPatients 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 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index must be 30-34.9 kg\m
- Clinical diagnosis of irritable bowel syndrome
- Must be Pre-diabetic HbA1c of 5.7 - 6.4.
- Must be sedentary subject
Key exclusion criteria (12 listed)
- Communication disorders
- Gasterointestinal bleeding
- Antibiotics or probiotics in the last 2 months
- Recent surgeries in the last 6 months
- Colorectal cancer or any terminal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moderate intensity continuous trainingAlso: high intensity interval training, low fermentable short chain carbohydrates diet (low FODMAP)exercise and diet | Other | high intensity interval training, low fermentable short chain carbohydrates diet, moderate intensity continuous training |
Primary outcome
Short Chain fatty acids
Time frame: before the start of the trial and at the end of the trial 3 months
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
Glucagon like peptide hormone
Time frame: before the start of the trial and at the end of the trial 3 months
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
3 secondary outcomes
Body Mass Index
Time frame: before the start of the trial and at the end of the trial 3 months
irritable bowel syndrome severity scoring system
Time frame: before the start of the trial and at the end of the trial 3 months
rritable bowel syndrome quality of life questionnaire
Time frame: before the start of the trial and at the end of the trial 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 33189181Aziz I, Simren M. The overlap between irritable bowel syndrome and organic gastrointestinal diseases. Lancet Gastroenterol Hepatol. 2021 Feb;6(2):139-148. doi: 10.1016/S2468-1253(20)30212-0. Epub 2020 Nov 13.
- Background: PubMed 36014798Cataldi S, Poli L, Sahin FN, Patti A, Santacroce L, Bianco A, Greco G, Ghinassi B, Di Baldassarre A, Fischetti F. The Effects of Physical Activity on the Gut Microbiota and the Gut-Brain Axis in Preclinical and Human Models: A Narrative Review. Nutrients. 2022 Aug 11;14(16):3293. doi: 10.3390/nu14163293.
- Background: PubMed 34945630Cella V, Bimonte VM, Sabato C, Paoli A, Baldari C, Campanella M, Lenzi A, Ferretti E, Migliaccio S. Nutrition and Physical Activity-Induced Changes in Gut Microbiota: Possible Implications for Human Health and Athletic Performance. Foods. 2021 Dec 10;10(12):3075. doi: 10.3390/foods10123075.
- Background: PubMed 33866297Chen L, Sun X, Khalsa AS, Bailey MT, Kelleher K, Spees C, Zhu J. Accurate and reliable quantitation of short chain fatty acids from human feces by ultra high-performance liquid chromatography-high resolution mass spectrometry (UPLC-HRMS). J Pharm Biomed Anal. 2021 Jun 5;200:114066. doi: 10.1016/j.jpba.2021.114066. Epub 2021 Apr 6.
- Background: PubMed 31937915Clark T, Morey R, Jones MD, Marcos L, Ristov M, Ram A, Hakansson S, Franklin A, McCarthy C, De Carli L, Ward R, Keech A. High-intensity interval training for reducing blood pressure: a randomized trial vs. moderate-intensity continuous training in males with overweight or obesity. Hypertens Res. 2020 May;43(5):396-403. doi: 10.1038/s41440-019-0392-6. Epub 2020 Jan 14.
- Background: PubMed 27070911DeGruttola AK, Low D, Mizoguchi A, Mizoguchi E. Current Understanding of Dysbiosis in Disease in Human and Animal Models. Inflamm Bowel Dis. 2016 May;22(5):1137-50. doi: 10.1097/MIB.0000000000000750.
- Background: PubMed 27117007Denou E, Marcinko K, Surette MG, Steinberg GR, Schertzer JD. High-intensity exercise training increases the diversity and metabolic capacity of the mouse distal gut microbiota during diet-induced obesity. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E982-93. doi: 10.1152/ajpendo.00537.2015. Epub 2016 Apr 26.
- Background: PubMed 32813140Elhosseiny D, Mahmoud NE, Manzour AF. Factors associated with irritable bowel syndrome among medical students at Ain Shams University. J Egypt Public Health Assoc. 2019 Dec 4;94(1):23. doi: 10.1186/s42506-019-0023-8.
- Background: PubMed 33545934Gupta AK, Maity C. Efficacy and safety of Bacillus coagulans LBSC in irritable bowel syndrome: A prospective, interventional, randomized, double-blind, placebo-controlled clinical study [CONSORT Compliant]. Medicine (Baltimore). 2021 Jan 22;100(3):e23641. doi: 10.1097/MD.0000000000023641.
- Background: PubMed 27259147Koh A, De Vadder F, Kovatcheva-Datchary P, Backhed F. From Dietary Fiber to Host Physiology: Short-Chain Fatty Acids as Key Bacterial Metabolites. Cell. 2016 Jun 2;165(6):1332-1345. doi: 10.1016/j.cell.2016.05.041.
- Background: PubMed 25623632Kuhre RE, Wewer Albrechtsen NJ, Hartmann B, Deacon CF, Holst JJ. Measurement of the incretin hormones: glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. J Diabetes Complications. 2015 Apr;29(3):445-50. doi: 10.1016/j.jdiacomp.2014.12.006. Epub 2014 Dec 15.
- Background: PubMed 28061847Lin L, Zhang J. Role of intestinal microbiota and metabolites on gut homeostasis and human diseases. BMC Immunol. 2017 Jan 6;18(1):2. doi: 10.1186/s12865-016-0187-3.
- Individual participant dataSharing planned: Yes. study protocol and final results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donia M Elmasry, Doctorate study director
Faculty of physiotherapy Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate intensity continuous training in people with Irritable Bowel Syndrome and Obesity, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Chain fatty acids (time frame: before the start of the trial and at the end of the trial 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06408610, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.