To determine the effect of oral probiotics on symptoms in patients with acute anal fissure refractory to standard treatment.
Design
A phase II, randomized, controlled, parallel-group, double-blind clinical trial will be conducted in 60 patients. Randomization will be performed using the Sealed Envelope online randomization service (https://www.sealedenvelope.com).
Settings and conduct
This study will be conducted in Yasuj, Iran. Patients with acute anal fissure confirmed by a specialist physician will be enrolled in the study. Participants will be followed for two weeks before and two weeks after the intervention. The intervention group will receive an oral probiotic capsule (Bio IBS), administered twice daily for 8 weeks, in addition to standard treatment. The control group will receive standard treatment + Placebo. The study will employ a double-blind design, with both the patients and the outcome assessor (surgeon) blinded to group allocation.
Participants/Inclusion and exclusion criteria
**Inclusion Criteria:**
* Patients aged ≥18 years with acute anal fissure confirmed by a specialist physician
**Exclusion Criterion:**
* Concomitant use of medications that may affect wound healing or immunosuppressive medications.
Intervention groups
**Intervention:** Participants in the intervention group will receive an oral probiotic capsule (Bio IBS), with each capsule containing three probiotic strains: *Lactobacillus casei*, *Lactobacillus rhamnosus*, and *Lactobacillus acidophilus*, providing a total of 5 × 10⁹ colony-forming units (CFUs) per capsule. The probiotic will be administered twice daily for 8 weeks in addition to standard treatment
**Control:** Participants in the control group will receive standard treatment alone, consisting of warm sitz baths, topical diltiazem anti-fissure ointment, and lactulose + Placebo
Main outcome variables
Pain; pruritus; bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260815070659N1
Registration date:2026-10-17, 1405/07/25
Registration timing:prospective
Last update:2026-10-17, 1405/07/25
Update count:0
Registration date
2026-10-17, 1405/07/25
Registrant information
Name
Hamid-Reza Ahmadi Amin Ahmadi Amin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5153
Email address
drahmadi256@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-22, 1405/07/30
Expected recruitment end date
2027-01-20, 1405/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Oral Probiotics on Symptoms in Patients with Treatment-Resistant Acute Anal Fissure: A controlled Clinical Trial
Public title
Effect of Oral Probiotics on Symptoms of Acute Treatment-Resistant Anal Fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age with physician-confirmed acute anal fissure
Less than 6 weeks since symptom onset
History of resistance to standard first-line treatment for 2 weeks
Exclusion criteria:
History of hypersensitivity or allergy to probiotic components
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated to the intervention and control groups using variable block randomization with block sizes of 2, 4, 6, and 8 and an allocation ratio of 1:1. The individual participant will be the unit of randomization. The random allocation sequence will be generated before participant recruitment using the online Sealed Envelope tool. The allocation sequence will be generated and maintained by an individual independent of participant recruitment and assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. After eligibility has been confirmed, informed consent has been obtained, and baseline assessments have been completed, the corresponding envelope will be opened in numerical order to reveal the participant’s group allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted using a double-blind design. The outcome assessor (surgeon) and data analyst will be blinded to group allocation and will be unaware of whether participants are assigned to the intervention or control group. The probiotic and placebo capsules will be identical in appearance, color, odor, and packaging. Participants will also be blinded to the intervention they receive.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Daneshgah St., Motahari Blvd., Jahad Town
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875111
Approval date
2026-07-15, 1405/04/24
Ethics committee reference number
IR.YUMS.REC.1405.085
Health conditions studied
1
Description of health condition studied
Acute anal fissure
ICD-10 code
K60.0
ICD-10 code description
Acute anal fissure
Primary outcomes
1
Description
Pain
Timepoint
2 weeks before the start of the intervention – 2 weeks after the end of the intervention
Method of measurement
visual analogue Scale (VAS)
2
Description
Pruritus ani
Timepoint
2 weeks before the start of the intervention – 2 weeks after the end of the intervention
Method of measurement
visual analogue Scale (VAS)
3
Description
Bleeding
Timepoint
2 weeks before the start of the intervention – 2 weeks after the end of the intervention
Method of measurement
Using a 4-point Likert scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in the intervention group will receive an oral probiotic capsule (Bio IBS) (Takgene Zist Company), with each capsule containing three probiotic strains: *Lactobacillus casei*, *Lactobacillus rhamnosus*, and *Lactobacillus acidophilus*, providing a total of 5 × 10⁹ colony-forming units (CFU) per capsule. The probiotic will be administered twice daily for 8 weeks, in addition to standard treatment, including warm sitz baths, topical diltiazem (Anti-Fissure) ointment, and lactulose.
Category
Treatment - Other
2
Description
Control group: Standard treatment, consisting of warm sitz baths, topical diltiazem (Anti-Fissure) ointment, and lactulose, will be administered for 8 weeks + Placebo
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh Clinic
Full name of responsible person
Amin Mareshi
Street address
Golestan12 St., Artesh Blvd., Golestan
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875111
Phone
+98 74 9101 3813
Email
cmofateh@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sirous Saleh nasab
Street address
Daneshgah St., Motahari Blvd., Jahad Town
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875111
Phone
+98 74 3334 6078
Email
research@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Majid Ahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Zarei Educational Campus, Beach Park Towards Imam Sajjad (AS) Hospital, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875111
Phone
+98 74 3323 5153
Email
majidahmadi1385@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Majid Ahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Zarei Educational Campus, Beach Park Towards Imam Sajjad (AS) Hospital, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875111
Phone
+98 74 3323 5153
Email
majidahmadi1385@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Majid Ahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Zarei Educational Campus, Beach Park Towards Imam Sajjad (AS) Hospital, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875111
Phone
+98 74 3323 5153
Email
majidahmadi1385@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After the completion of the study, all study data will be shared after being de-identified
When the data will become available and for how long
One month after the completion of the intervention, the data of the main variables of the study will be shared.
To whom data/document is available
The study data will be available to academic and scientific researchers working at medical science centers.
Under which criteria data/document could be used
Individuals associated with the medical and therapeutic fields may utilize the data from this study to conduct new research.
From where data/document is obtainable
Via official email to the corresponding author at: majidahmadi1385@yahoo.com
What processes are involved for a request to access data/document
The applicant must submit their formal request via the organization's email to the responsible author's email address. The accountable author will provide the information to the applicant within a maximum of 2 weeks after the applicant confirms the information.