Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607728633353 Date of Registration: 24/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Can Probiotics Improve Symptoms and Quality of Life in People with Irritable Bowel Syndrome?
Official scientific title ffects of Probiotic Supplementation on Symptom Severity and Quality of Life in Patients with Irritable Bowel Syndrome: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Irritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder characterized by abdominal pain, bloating, and altered bowel habits, affecting an estimated 10–20% of the global population. Its causes are multifactorial and include alterations in the gut microbiota, disruption of the gut–brain axis, and psychological factors. Current treatments focus mainly on symptom control through dietary, psychological, and pharmacological approaches, but these may cause side effects, nutritional deficiencies, or increased healthcare use. Probiotics—live microorganisms that provide a health benefit when administered in adequate amounts—have emerged as a promising option, with growing evidence that they can reduce IBS symptoms and improve quality of life. However, data from Tunisian patients remain scarce. This study aims to evaluate the effects of probiotic supplementation on symptom severity and quality of life in patients with irritable bowel syndrome. The primary objective is to assess the change in IBS symptom severity, and the secondary objective is to assess the change in patients' quality of life following probiotic supplementation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 14/12/2025
Actual trial start date 14/12/2025
Anticipated date of last follow up 28/01/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group probiotic 1 month Patients with IBS received oral probiotic supplementation (Ultragermina®) for one month. Each capsule contained four microbial strains—Bifidobacterium longum, Lactobacillus helveticus, Lactococcus lactis, and Streptococcus thermophilus—at a total dose of 10 billion CFU (1 × 10¹⁰ CFU) per capsule, taken once daily fasting 25
Control Group placebo 1 month Patients with IBS received a matching placebo, identical in appearance, taste, and packaging to the probiotic supplement, once daily for one month. 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: Patients aged 18 to 64 years. Confirmed diagnosis: IBS diagnosed according to the Rome IV criteria, after exclusion of any organic disease. Digestive symptoms: Presence of digestive symptoms persisting for at least 6 months before diagnosis, including abdominal pain, bloating, and altered bowel habits. Informed consent: Ability to provide informed consent to participate in the study, understanding of the study objectives, and willingness to comply with the study schedule (visits, questionnaires, and treatment intake). Other gastrointestinal disorders: Presence of an active or known organic gastrointestinal disease, including inflammatory bowel disease (Crohn's disease, ulcerative colitis), celiac disease, digestive cancer, or a history of major intestinal resection. Unexplored alarm symptoms: Rectal bleeding, significant unintentional weight loss, or unexplained anemia. Severe uncontrolled comorbidities: Severe heart failure, end-stage renal disease, or decompensated liver disease. Use of other supplements or medications: Recent use of medications affecting intestinal motility or the gut microbiota, or of other supplements that could interfere with the study results, such as probiotics. Pregnancy or breastfeeding. Psychiatric or cognitive disorders: Severe, unstabilized disorders affecting the patient's ability to complete questionnaires or follow study instructions. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/12/2025 Ethics Committee of the Charles Nicolle Hospital
Ethics Committee Address
Street address City Postal code Country
Charles Nicolle Hospital, Boulevard 9 Avril 1938, Tunis 1006, Tunisia tunis 1007 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in IBS symptom severity from baseline to one month, assessed using the [IBS Symptom Severity Scale (IBS-SSS)]. post intervention
Secondary Outcome Change in quality of life from baseline to one month, assessed using the [IBS Quality of Life questionnaire (IBS-QoL)]. post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Gastroenterology Charles Nicolle Hospital Boulevard 9 Avril 1938, Tunis 1006, Tunisie tunis 1007 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Rym Ben Othman 11 rue jbal lakhdhar tunis Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor xen 10 rue Ibn Maja megrine Tunisia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator rym ben othman benothmanr@gmail.com +21699907402 11 rue jbal lakhdhar
City Postal code Country Position/Affiliation
tunis Tunisia faculty of medicine of tunis
Role Name Email Phone Street address
Public Enquiries nour ncibi nourncibi13@gmail.com +21693255510 bab saadoun
City Postal code Country Position/Affiliation
tunis Tunisia Higher School of Health Sciences and Techniques of Tunis
Role Name Email Phone Street address
Scientific Enquiries asma mensi asma.mensi@fmt.utm.tn +21629280099 boulevard 9 avril
City Postal code Country Position/Affiliation
tunis Tunisia charles nicole hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data (IPD) that underlie the results reported in this study, after de-identification, may be made available upon reasonable request to the corresponding author, subject to approval by the study investigators and in compliance with applicable ethical and data protection regulations. Informed Consent Form Data will be available beginning 6 months after publication of the main results and ending 5 years after publication. Data will be shared with researchers who provide a methodologically sound proposal, approved by the study investigators. Access will be granted for the purpose of achieving the aims stated in the approved proposal (for example, individual patient data meta-analysis). Requests should be directed to the corresponding author at [e-mail]. Data will be shared after signature of a data access agreement and in compliance with applicable ethical and data protection regulations.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 24/07/2026 PACTR Admin 14 Dec 2025
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 15/07/2026 thank you for your comment Primary Outcome, Change in IBS symptom severity from baseline to one month, assessed using the [IBS Symptom Severity Scale (IBS-SSS)]., 30 days Primary Outcome, Change in IBS symptom severity from baseline to one month, assessed using the [IBS Symptom Severity Scale (IBS-SSS)]., post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 15/07/2026 thank you for your comment Secondary Outcome, Change in quality of life from baseline to one month, assessed using the [IBS Quality of Life questionnaire (IBS-QoL)]., 30 days Secondary Outcome, Change in quality of life from baseline to one month, assessed using the [IBS Quality of Life questionnaire (IBS-QoL)]., post intervention
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/07/2026 i have written the exact name in french TRUE, ethical comitee of charles nicole hospital, Charles Nicolle Hospital, Boulevard 9 Avril 1938, Tunis 1006, Tunisia, tunis, 1007, Tunisia, , 09 Dec 2025, +21694626428, ethique.hcn@gmail.com, 43677_40000_4737.pdf TRUE, Ethics Committee of the Charles Nicolle Hospital, Charles Nicolle Hospital, Boulevard 9 Avril 1938, Tunis 1006, Tunisia, tunis, 1007, Tunisia, , 09 Dec 2025, +21694626428, ethique.hcn@gmail.com, 43677_40000_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 15/07/2026 thank you for your comment it is a self funded study none, none none, tunis, , Tunisia, , principal investigator, 11 rue jbal lakhdhar, tunis, , Tunisia, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 23/07/2026 i added the name of the principal investigator. sorry for the misunderstanding principal investigator, 11 rue jbal lakhdhar, tunis, , Tunisia, Self Funded, Rym Ben Othman, 11 rue jbal lakhdhar, tunis, , Tunisia, Self Funded,