Evaluation of the effect of probiotics in preventing low anterior resection syndrome

Evaluation of the effect of probiotics in preventing lower rectal resection syndrome in patients with rectal cancer who have undergone lower anterior rectal resection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210704051784N1

Enrollment

180

Registered

2021-10-26

Start date

2021-11-21

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with rectal cancer whose adenocarcinoma is pathologically proven and indicated for anterior resection.. Malignant neoplasm of colon, unspecified

Interventions

Intervention 1: Intervention group: Multilateral probiotics in the form of LactoCare capsules made by Zist-Takhmir Company will be given to patients every 12 hours (after lunch and after dinner) for 4

Eligibility

Sex/Gender

All

Age

18 Years to 57 Years

Inclusion criteria

Inclusion criteria: Age 18 to 57 years Indicated removal of the anterior part of the lower rectum Confirmed adenocarcinoma Ability to fill out a questionnaire Patients with Rectal cancers whom undergone radiotherapy

Exclusion criteria

Exclusion criteria: Use antibiotics or probiotics a week before Systemic evidence of obstruction in preoperative endoscopy Urinary and fecal incontinence Metastatic cancer Advanced cardiovascular and cerebral disease Pregnant and lactating mothers Irritable Bowel Syndrome History of chemotherapy or radiotherapy Symptoms of infection or immunodeficiency disease Abnormal creatinine Abnormal liver enzymes Uncontrolled hypertension or diabetes Patients with celiac disease or probiotic intolerance

Design outcomes

Primary

Measure	Time frame
Level of Quality of Life. Timepoint: The questionnaire will be completed by the patients of both groups once before starting the drug treatment and after that by the patient every week. Method of measurement: The Gastrointestinal Quality of Life Questionnaire consists of 36 different items that include general and specific symptoms, physical and mental functioning, and social dysfunction related to gastrointestinal diseases. Each item has a score from 0 to 4. The score of this questionnaire is from 0 to 144, of which 0 is the worst possible case and 144 is the best possible case. The Anterior Resect Syndrome Questionnaire examines 5 important questions, including 1. Incontinence for stool 2. Incontinence for liquid stool 3. Frequency 4. Clustering 5. Urgency. The score of this questionnaire is from 0 to 42, according to which if the patient scores 0 to 20, he does not have anterior resection syndrome. A score of 21 to 29 indicates a mild form of the syndrome, and a score of 30 to 42 indicates a severe form.	—

Measure

Time frame

Level of Quality of Life. Timepoint: The questionnaire will be completed by the patients of both groups once before starting the drug treatment and after that by the patient every week. Method of measurement: The Gastrointestinal Quality of Life Questionnaire consists of 36 different items that include general and specific symptoms, physical and mental functioning, and social dysfunction related to gastrointestinal diseases. Each item has a score from 0 to 4. The score of this questionnaire is from 0 to 144, of which 0 is the worst possible case and 144 is the best possible case. The Anterior Resect Syndrome Questionnaire examines 5 important questions, including 1. Incontinence for stool 2. Incontinence for liquid stool 3. Frequency 4. Clustering 5. Urgency. The score of this questionnaire is from 0 to 42, according to which if the patient scores 0 to 20, he does not have anterior resection syndrome. A score of 21 to 29 indicates a mild form of the syndrome, and a score of 30 to 42 indicates a severe form.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNima Afshari pour

Tehran University of Medical Sciences

nimaa770@gmail.com+98 21 6634 8500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026