Skip to content

Investigating the effect of probiotic products in preventing or reducing the duration of ileus after Roux-en-Y gastric bypass surgery, a double-blind randomized controlled trial

“Effect of Oral Probiotics on Prevention/Reduction of Postoperative Ileus after Roux-en-Y Gastric Bypass: A Double-Blind Randomized Controlled Trial.”

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250902067084N1
Enrollment
68
Registered
2025-09-12
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Ileus caused by gastric bypass surgery (Roux-en-Y gastric bypass). Paralytic ileus

Interventions

Intervention 1: Intervention group: Patients undergoing open Roux-en-Y gastric bypass at Imam Reza Hospital (Mashhad, Iran) will receive oral probiotic capsules starting 24 hours after surgery, 2 caps
labeled 10^18 CFU per capsule
Iran-made). Allocation is randomized with equal assignment and the trial is double-blind (participants, care team, and outcome assessors). All participants receive standard postoperative care equally

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patient presenting for bypass surgery Performing laparotomy surgery on the patient Patient must be between 18 and 60 years old, have informed consent from the patient Complete patient medical record No underlying medical conditions, clinical history, and specific conditions such as diabetes and hypertension, pregnancy, psychiatric problems, disability, or organ defects No nasogastric tube No clinical history or histological confirmation of inflammatory bowel disease

Exclusion criteria

Exclusion criteria: Refusal to continue the study or take medication Failure to take medication at the prescribed time and in the prescribed amount Withdrawal from the study due to transfer to another hospital or sudden personal consent or death of the patient or occurrence of an emergency condition in the patient Leakage of the intestinal anastomosis

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative ileus, defined as a total score equal to or greater than six on the five-item scoring system of Intake, Feeling nauseated, Emesis (vomiting), physical Examination of the abdomen for distension, and Duration of symptoms, assessed during the postoperative hospitalization after Roux-en-Y gastric bypass surgery. Timepoint: Once daily beginning twenty-four hours after surgery (postoperative day 1) and every twenty-four hours thereafter until hospital discharge. Method of measurement: Bedside clinical assessment using the five-item scoring system of Intake, Feeling nauseated, Emesis (vomiting), physical Examination of the abdomen for distension, and Duration of symptoms; each item is scored from zero to three, the total score ranges from zero to fifteen, and postoperative ileus is defined as a total score equal to or greater than six. Data are recorded on standardized case-report forms and the patient’s medical record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHashem Fathi

Torbate-Heidaria University of Medical Sciences

hashemfathi79@gmail.com+98 51 5726 3251

Outcome results

None listed

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