Irritable Bowel SyndromeNCT07256262
Effect of Functional Magnetic Therapy on Constipation Predominant- Irritable Bowel Syndrome (IBS-C)
A study testing Functional magnetic stimulation (FMS) and Conventional pharmacological therapy in people with Irritable Bowel Syndrome, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the potential benefits of functional magnetic therapy on constipation improvement and related symptoms in patients with IBS-C, including abdominal pain, bloating, bowel habits, and quality of life, as well as to assess patient satisfaction and experience with the therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Functional magnetic stimulation (FMS) and Conventional pharmacological therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2025to 14 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of IBS-C based on Rome IV criteria.
- Age: Adults aged 18-65 years.
- Symptom Duration: Symptoms present for at least 6 months before diagnosis.
- Ability to Consent: Patients must be able to provide informed consent and comply with study requirements.
Who cannot join
- Presence of Alarm Features or Red Flags:
- Unexplained weight loss.
- Blood in stool or rectal bleeding.
- Anaemia (iron deficiency anaemia).
- Persistent vomiting.
- Underlying Organic Diseases:
Show all 15Show fewer
- Conditions such as inflammatory bowel disease (IBD), celiac disease, colorectal cancer, or other structural gastrointestinal abnormalities.
- Pregnancy or Lactation.
- Surgery or Anatomic Alterations: History of major gastrointestinal surgeries (e.g., bowel resection) that could affect bowel function.
- Contraindications to the Procedure:
- Patients with pacemaker
- Condition that can compromise increased abdominal pressure, such as hernia.
- Condition that can prevent adequate performance of abdominal muscle tension.
- Recent thoracic or abdominal surgery precluding the use of functional magnetic therapy.
- Rib fractures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tamer I Abo Elyazed, PhD contact
Egypt1 site
Beni-Suef University
Banī Suwayf
Amira Ali Gaber Ali, +20 102 366 0326, Amira.ali_2160218@student.deraya.edu.eg
About this study
The aim of this study is to evaluate the potential benefits of functional magnetic therapy on constipation improvement and related symptoms in patients with IBS-C, including abdominal pain, bloating, bowel habits, and quality of life, as well as to assess patient satisfaction and experience with the therapy.
Read the detailed description
Functional magnetic stimulation (FMS) has emerged as a promising non-invasive therapeutic approach for managing irritable bowel syndrome (IBS) with predominant constipation, operating through the application of electromagnetic fields that induce electrical currents to modulate neural activity and gastrointestinal function.
Previous research has demonstrated multiple therapeutic benefits of FMS including enhanced bowel motility, increased rectal pain thresholds leading to reduced abdominal pain, improved visceral hypersensitivity, and alleviation of associated psychological symptoms such as anxiety and depression in patients with functional bowel disorders.
The TESLA Former is a high-intensity Functional Magnetic Stimulation (FMS) device, that operates through multiple therapeutic mechanisms in treating IBS with predominant constipation: it delivers electromagnetic pulses to strengthen pelvic floor muscles and enhance defecation dynamics while modulating the brain-gut axis through stimulation of pudendal and sacral nerves (S2-S4); additionally, it influences the enteric nervous system (ENS) to normalize gut peristalsis and bowel transit, while simultaneously reducing inflammation and stress response through autonomic nervous system modulation, ultimately addressing both the physical and psychological components of IBS by improving muscle coordination, reducing visceral hypersensitivity, and promoting a balanced gut microbiota environment.
Research has demonstrated that the TESLA Former delivers significant therapeutic outcomes in treating IBS, including improved bowel function with increased frequency and ease of bowel movements, reduced abdominal discomfort manifested through diminished bloating and visceral pain, and enhanced quality of life (QOL) through reduced laxative dependency and improved symptom control; notably, this non-invasive therapy demonstrates excellent safety and tolerability profile.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Functional magnetic stimulation (FMS), Conventional pharmacological therapy
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic stimulation (FMS)Device
Every patient will receive 20-minute FMS sessions on the TESLA FORMER device. Each treatment session will consist of one cycle (20 minutes each) based on the treatment area's size and the investigator's discretion. Treatment will be administered by a single applicator secured directly over the abdominal muscles. The device's output intensity will be escalated to a tolerable level depending on patient feedback, with average maximum intensities ranging from 98% to 100% across treatment sessions. The treatment will be 20 minutes long, with several steps including different frequency modulations to achieve stimulation of different muscle fibres.
Conventional pharmacological therapyDrug
Every patient in both groups will receive conventional pharmacological therapy for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Functional magnetic stimulation (FMS) + Conventional pharmacological therapy | Experimental | It will receive Trans-abdominal FMS plus the conventional pharmacological therapy for 8 weeks. Receives: Device: Functional magnetic stimulation (FMS); Drug: Conventional pharmacological therapy |
| Conventional pharmacological therapy | Other | It will receive the conventional pharmacological therapy for 8 weeks. Receives: Drug: Conventional pharmacological therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Severity Scoring System (IBS-SSS)
It is a tool used to assess the severity of symptoms in patients with irritable bowel syndrome (IBS). It consists of five key questions that measure the intensity and impact of symptoms such as abdominal pain, bloating, bowel movement frequency, and the overall effect of IBS on QOL. Each symptom is rated on a scale from 0 to 100, and the total score ranges from 0 to 500. The total score helps categorize the severity of IBS as mild (75-175), moderate (175-300), or severe (300-500). The IBS-SSS is valuable for clinicians to monitor symptom progression, evaluate treatment effectiveness, and track the impact of IBS on a patient's daily life.
Measured: 8 weeks
Complete Spontaneous Bowel Movements (CSBMs)
A complete spontaneous bowel movement (CSBM) is defined as a natural, voluntary bowel movement without the need for medical intervention, medications, or external aids. It involves the elimination of waste with a feeling of complete evacuation, occurring regularly (from three times a week to three times a day). CSBM typically is accompanied by the sensation of complete emptying and occurs without laxative use in the previous 24 hours, indicating normal gastrointestinal health and function. It is used as a clinical marker to evaluate digestive health, particularly in assessing conditions like irritable bowel syndrome.
Measured: 8 weeks
Bristol Stool Scale Assessment (BSS)
It is a medical tool used to classify stool consistency and type, helping in assessing bowel health. The scale consists of seven types of stool, ranging from Type 1 (hard and lumpy) to Type 7 (liquid and watery). Types 3 and 4 are generally considered normal, with Type 3 resembling a sausage shape with cracks and Type 4 being smooth and soft, similar to a sausage or snake. It helps in monitoring bowel function, determining the effectiveness of treatments, and providing insight into gastrointestinal health.
Measured: 8 weeks
Secondary outcomes (3)
The Visual Analog Scale (VAS)
The VAS consists of a straight line, typically 10 cm in length, where one end represents "no pain" and the other end represents "worst possible pain". Patients will be asked to mark a point on the line that represents the severity of their pain, with the position of the mark indicating their pain level. The scale is then measured in centimetres or millimeters, with higher values indicating more intense pain.
Measured: 8 weeks
Pain Interference with Activities
It refers to the interference of pain with different activities such as walking, sitting, working light or heavy work and It grades from (None □ Mild □ Moderate □ Severe Complete).
Measured: 8 weeks
Patient Assessment of Constipation Quality of Life (PAC-QOL )
It is a self-reported questionnaire designed to assess the impact of constipation on a patient's quality of life. It helps evaluate the psychological, social, and physical effects of constipation on daily living. The questionnaire consists of a series of statements that the patient rates based on their experiences over the past week, with responses typically ranging from "not at all" to "very much. The PAC-QOL is divided into four domains.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start28 Nov 2025 (estimated)
- Primary completion28 Jan 2026 (estimated)
- Study completion14 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ali Gaber Ali, Beni-Suef University
- Investigators
- Tamer I Abo Elyazed, PhD, Study chair, Assistant Professor, Beni-Suef UniversityRagaey Ahmad Eid, PhD, Study director, Assistant Professor, Beni-Suef UniversityMarwa Mohamed Eleawa, Study director, Lecturer, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256262
- Sponsor's protocol ID
- FPTBSUREC/0204/2225
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Magnetic Therapy on Constipation Predominant- Irritable Bowel Syndrome (IBS-C)
- ClinicalTrials.gov ID
- NCT07256262
- Acronym / sponsor ID
- FPTBSUREC/0204/2225
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 28 Nov 2025 (estimated)
- Primary completion
- 28 Jan 2026 (estimated)
- Study completion
- 14 Feb 2026 (estimated)
- First posted
- 1 Dec 2025 (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.
The aim of this study is to evaluate the potential benefits of functional magnetic therapy on constipation improvement and related symptoms in patients with IBS-C, including abdominal pain, bloating, bowel habits, and quality of life, as well as to assess patient satisfaction and experience with the therapy.
Detailed description
Functional magnetic stimulation (FMS) has emerged as a promising non-invasive therapeutic approach for managing irritable bowel syndrome (IBS) with predominant constipation, operating through the application of electromagnetic fields that induce electrical currents to modulate neural activity and gastrointestinal function.
Previous research has demonstrated multiple therapeutic benefits of FMS including enhanced bowel motility, increased rectal pain thresholds leading to reduced abdominal pain, improved visceral hypersensitivity, and alleviation of associated psychological symptoms such as anxiety and depression in patients with functional bowel disorders.
The TESLA Former is a high-intensity Functional Magnetic Stimulation (FMS) device, that operates through multiple therapeutic mechanisms in treating IBS with predominant constipation: it delivers electromagnetic pulses to strengthen pelvic floor muscles and enhance defecation dynamics while modulating the brain-gut axis through stimulation of pudendal and sacral nerves (S2-S4); additionally, it influences the enteric nervous system (ENS) to normalize gut peristalsis and bowel transit, while simultaneously reducing inflammation and stress response through autonomic nervous system modulation, ultimately addressing both the physical and psychological components of IBS by improving muscle coordination, reducing visceral hypersensitivity, and promoting a balanced gut microbiota environment.
Research has demonstrated that the TESLA Former delivers significant therapeutic outcomes in treating IBS, including improved bowel function with increased frequency and ease of bowel movements, reduced abdominal discomfort manifested through diminished bloating and visceral pain, and enhanced quality of life (QOL) through reduced laxative dependency and improved symptom control; notably, this non-invasive therapy demonstrates excellent safety and tolerability profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional magnetic stimulation (FMS) + Conventional pharmacological therapy | Experimental | Device: Functional magnetic stimulation (FMS), Drug: Conventional pharmacological therapyIt will receive Trans-abdominal FMS plus the conventional pharmacological therapy for 8 weeks. |
| Conventional pharmacological therapy | Other | Drug: Conventional pharmacological therapyIt will receive the conventional pharmacological therapy for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of IBS-C based on Rome IV criteria.
- Age: Adults aged 18-65 years.
- Symptom Duration: Symptoms present for at least 6 months before diagnosis.
- Ability to Consent: Patients must be able to provide informed consent and comply with study requirements.
Key exclusion criteria (15 listed)
- Presence of Alarm Features or Red Flags:
- Underlying Organic Diseases:
- Pregnancy or Lactation.
- Surgery or Anatomic Alterations: History of major gastrointestinal surgeries (e.g., bowel resection) that could affect bowel function.
- Contraindications to the Procedure:
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 |
|---|---|---|
| Functional magnetic stimulation (FMS)Every patient will receive 20-minute FMS sessions on the TESLA FORMER device. Each treatment session will consist of one cycle (20 minutes each) based on the treatment area's size and the investigator's discretion. Treatment will be administered by a single applicator secured directly over the abdominal muscles. The device's output intensity will be escalated to a tolerable level depending on patient feedback, with average maximum intensities ranging from 98% to 100% across treatment sessions. The treatment will be 20 minutes long, with several steps including different frequency modulations to achieve stimulation of different muscle fibres. | Device | Functional magnetic stimulation (FMS) + Conventional pharmacological therapy |
| Conventional pharmacological therapyEvery patient in both groups will receive conventional pharmacological therapy for 8 weeks. | Drug | Conventional pharmacological therapy, Functional magnetic stimulation (FMS) + Conventional pharmacological therapy |
Primary outcome
IBS Severity Scoring System (IBS-SSS)
Time frame: 8 weeks
It is a tool used to assess the severity of symptoms in patients with irritable bowel syndrome (IBS). It consists of five key questions that measure the intensity and impact of symptoms such as abdominal pain, bloating, bowel movement frequency, and the overall effect of IBS on QOL. Each symptom is rated on a scale from 0 to 100, and the total score ranges from 0 to 500. The total score helps categorize the severity of IBS as mild (75-175), moderate (175-300), or severe (300-500). The IBS-SSS is valuable for clinicians to monitor symptom progression, evaluate treatment effectiveness, and track the impact of IBS on a patient's daily life.
Complete Spontaneous Bowel Movements (CSBMs)
Time frame: 8 weeks
A complete spontaneous bowel movement (CSBM) is defined as a natural, voluntary bowel movement without the need for medical intervention, medications, or external aids. It involves the elimination of waste with a feeling of complete evacuation, occurring regularly (from three times a week to three times a day). CSBM typically is accompanied by the sensation of complete emptying and occurs without laxative use in the previous 24 hours, indicating normal gastrointestinal health and function. It is used as a clinical marker to evaluate digestive health, particularly in assessing conditions like irritable bowel syndrome.
Bristol Stool Scale Assessment (BSS)
Time frame: 8 weeks
It is a medical tool used to classify stool consistency and type, helping in assessing bowel health. The scale consists of seven types of stool, ranging from Type 1 (hard and lumpy) to Type 7 (liquid and watery). Types 3 and 4 are generally considered normal, with Type 3 resembling a sausage shape with cracks and Type 4 being smooth and soft, similar to a sausage or snake. It helps in monitoring bowel function, determining the effectiveness of treatments, and providing insight into gastrointestinal health.
3 secondary outcomes
The Visual Analog Scale (VAS)
Time frame: 8 weeks
Pain Interference with Activities
Time frame: 8 weeks
Patient Assessment of Constipation Quality of Life (PAC-QOL )
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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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.
Tamer I Abo Elyazed, PhD contact
Tamer I Abo Elyazed, PhD study chair
Assistant Professor, Beni-Suef University
Ragaey Ahmad Eid, PhD study director
Assistant Professor, Beni-Suef University
Marwa Mohamed Eleawa study director
Lecturer, Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic stimulation (FMS) and Conventional pharmacological therapy in people with Irritable Bowel Syndrome, run by Beni-Suef University at 1 site 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 15 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: opening soon, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Ali Gaber Ali, B.Sc (+20 102 366 0326, Amira.ali_2160218@student.deraya.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS Severity Scoring System (IBS-SSS) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2025.