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Irritable Bowel Syndrome With DiarrheaPhase 4NCT05867550

To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea

A Phase 4 study testing Rifaximin 550 MG, Mebeverine 135 MG and Psyllium Husk in people with Irritable Bowel Syndrome With Diarrhea, run by Bahria University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to compare the efficacy of four different drugs in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is: Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Irritable Bowel Syndrome With Diarrhea
What is being tested?
Rifaximin 550 MG, Mebeverine 135 MG and Psyllium Husk
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 sitePakistan
Study dates
3 Jan 2023to 10 Jun 2023
Phase
Phase 4
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 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Individual of both gender between the age of 18-50 years Diagnosed case of Irritable Bowel Syndrome associated with Diarrhea

Who cannot join

  • Presence of co morbid diseases
  • Coronary Artery Disease (CAD)
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Congestive Heart Failure (CHF)
  • Patients taking drugs which modify or aggravate symptoms of IBS (antidepressants, calcium channel blockers etc.)
  • Patients having hyperthyroidism \& gluten hypersensitivity
Show all 9Show fewer
  • Patients with alarming symptoms, viz. history of fever, passage of blood in stool, loss of weight, any organic gastrointestinal disease in the recent past
  • Patients with recent change in bowel habits, patients on any other concomitant medication for abdominal pain, bowel disturbance or altering gastrointestinal motility and malignancy of any other organ
  • Patients with Irritable Bowel Disease and Celiac disease

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Bahria University Health Sciences Campus

    Karachi, Sindh

Other trials in Pakistan

About this study

Official title: To Compare the Efficacy of (Rifaximin + Mebeverine), (Rifaximin + Amitriptyline), and (Rifaximin + Psyllium Husk) in Irritable Bowel Syndrome Associated With Diarrhea

The goal of this clinical trial is to compare the efficacy of four different drugs in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is:

  • Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea?

Participants will be divided into 3 treatment groups.

  • Each group will be given a combination of drugs for 2 weeks
  • At the end of study, efficacy of different drug combinations and their potential side effects will be compared between the treatment groups
Read the detailed description

The goal of this clinical trial is to compare the efficacy of four different drugs (Rifaximin , Mebeverine, Amitriptyline and Psyllium Husk) in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is:

  • Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea?

Total of 162 Participants will be enrolled in study.

  • Participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C.
  • Participants of Group A will receive drug combination of Rifaximin and Mebeverine
  • Participants of Group B will receive drug combination of Rifaximin and Amitriptyline
  • Participants of Group C will receive drug combination of Rifaximin and Psyllium Husk
  • Each group will be given a combination of drugs for 2 weeks

Stool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention

Data will be collected using Questionnaire. Questionnaire will be filled by the researcher

SPSS will be used for analysis of data and appropriate test like Chi square Test, Student T test and One way ANOVA will be used to draw conclusions about the efficacy of different drug combinations and their potential side effects between the treatment groups

Being tested
Rifaximin 550 MG, Mebeverine 135 MG, Psyllium Husk, Amitriptyline Hydrochloride 25 MG
Keywords
Irritable Bowel Syndrome, Diarrhea, IBS-D
Medical subject headings
Irritable Bowel Syndrome, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rifaximin 550 MGDrug

    Also called Rifaxa 550MG, Nimixa 550 MG, Xifaxa 550MG, Zerifax 550MG

    Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C

  • Mebeverine 135 MGDrug

    Also called Colofac 135 MG, Spasler Neo 135 MG, Mebever 135 MG

    Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes

  • Psyllium HuskDrug

    Also called Ispaghol

    Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes

  • Amitriptyline Hydrochloride 25 MGDrug

    Also called Tryptanol 25 MG

    Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes

Study groups in NCT05867550
Study groupRoleWhat they receive
Group A ( Rifaximin + Mebeverine )Active comparatorTab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Mebeverine 135mg twice daily per orally for 2 weeks
Receives: Drug: Rifaximin 550 MG; Drug: Mebeverine 135 MG
Group B ( Rifaximin + Amitriptyline )Active comparatorTab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Amitriptyline 25mg once daily per orally for 2 weeks
Receives: Drug: Rifaximin 550 MG; Drug: Amitriptyline Hydrochloride 25 MG
Group C ( Rifaximin + Psyllium Husk )Active comparatorTab. Rifaximin 550mg thrice daily per orally for 2 weeks Psyllium Husk 15-30mg once daily per orally for 2 weeks
Receives: Drug: Rifaximin 550 MG; Drug: Psyllium Husk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Improvement in Frequency of Diarrhea

    The study will assess change in number of stools per day from day 0 to day 14

    Measured: 2 Weeks

  2. Overall Improvement in Characteristic of Diarrhea

    The study will assess change in characteristic of stool type from type 6,7 to 4 according to Bristol Stool Chart from day 0 to day 14

    Measured: 2 Weeks

  3. Overall Improvement in Abdominal Pain

    The study will assess change in abdominal pain from day 0 to day 14

    Measured: 2 Weeks

  4. Compare Efficacy of Treatment Regimes in Treatment Groups

    The study will assess and compare the effect of each treatment regime on reduction of diarrhea, improvement in abdominal pain among the treatment groups

    Measured: 4 Weeks

Secondary outcomes (1)

  1. To observe adverse effects of treatment regimes

    The study will observe number of participants with adverse effects like Nausea, Stomachache, Dizziness, Tiredness, Joint Pain, Headache, Heartburn, Constipation, Dry Mouth, Sedation and Bloating of drugs in different groups and compare them

    Measured: 2 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start3 Jan 2023
  3. Primary completion27 Mar 2023
  4. Study completion10 Jun 2023

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Control Trial in which participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C. * Participants of Group A will receive drug combination of Rifaximin and Mebeverine * Participants of Group B will receive drug combination of Rifaximin and Amitriptyline * Participants of Group C will receive drug combination of Rifaximin and Psyllium Husk * Each group will be given a combination of drugs for 2 weeks Stool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention At the end of study period , efficacy of different drug combinations and their potential side effects will be compared between the treatment groups
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05867550
Sponsor's protocol ID
ERC 106/2022
Status last verified
Jul 2023
First submitted
4 Apr 2023
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD data will be shared

Publications

  • Alaqeel MK, Alowaimer NA, Alonezan AF, Almegbel NY, Alaujan FY. Prevalence of Irritable Bowel Syndrome and its Association with Anxiety among Medical Students at King Saud bin Abdulaziz University for Health Sciences in Riyadh. Pak J Med Sci. 2017 Jan-Feb;33(1):33-36. doi: 10.12669/pjms.331.12572.

    PubMed 28367168

  • Altomare A, Di Rosa C, Imperia E, Emerenziani S, Cicala M, Guarino MPL. Diarrhea Predominant-Irritable Bowel Syndrome (IBS-D): Effects of Different Nutritional Patterns on Intestinal Dysbiosis and Symptoms. Nutrients. 2021 Apr 29;13(5):1506. doi: 10.3390/nu13051506.

    PubMed 33946961

  • Axelrod CH, Saps M. The Role of Fiber in the Treatment of Functional Gastrointestinal Disorders in Children. Nutrients. 2018 Nov 3;10(11):1650. doi: 10.3390/nu10111650.

    PubMed 30400292

  • Bachani P, Kumar L, Kumar N, Fatima M, Naz S, Memon MK, Memon S, Rizwan A. Prevalence of Irritable Bowel Syndrome and Frequency of Symptoms in the General Population of Pakistan. Cureus. 2021 Jan 6;13(1):e12541. doi: 10.7759/cureus.12541.

    PubMed 33564537

  • Bai T, Xia J, Jiang Y, Cao H, Zhao Y, Zhang L, Wang H, Song J, Hou X. Comparison of the Rome IV and Rome III criteria for IBS diagnosis: A cross-sectional survey. J Gastroenterol Hepatol. 2017 May;32(5):1018-1025. doi: 10.1111/jgh.13642.

    PubMed 27862281

  • Barbara G, Cremon C, Azpiroz F. Probiotics in irritable bowel syndrome: Where are we? Neurogastroenterol Motil. 2018 Dec;30(12):e13513. doi: 10.1111/nmo.13513.

    PubMed 30460770

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rifaximin 550 MG, Mebeverine 135 MG and Psyllium Husk in people with Irritable Bowel Syndrome With Diarrhea, run by Bahria University at 1 site in Pakistan.

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 1 inclusion and 9 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 27 Jul 2023. 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 Pakistan. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Overall Improvement in Frequency of Diarrhea (time frame: 2 Weeks). The study lists 4 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 NCT05867550, which also lists 6 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 27 Jul 2023.

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