The Effect of Probiotics Supplementation on Expression of Osteoprotegerin and Receptor Activator of Nuclear Factor Kappa Beta Ligand Genes, Serum Levels of C- terminal Telopeptide of Type I Collagen and Osteocalcin, Anthropometric Indices, Body Composition, and Quality of Life After Sleeve Gastrectomy: A Randomised Controlled Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240115060696N1

Enrollment

Registered

2024-03-26

Start date

2024-04-21

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Condition 1: Bone disorders. Condition 2: obesity. Condition 3: Gastrointestinal symptoms. Disorder of bone density and structure, unspecified Overweight and obesity Disease of digestive system, unspecified

Interventions

Intervention 1: Intervention group: Intervention group will receive daily 1 capsule of probiotics supplement for 12 weeks. Probiotics will be purchased from the Zist Takhmir Company. All the patients

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Obese patients undergoing gastric sleeve laparoscopic surgery. Age above 18 years. Willingness to cooperate in the study.

Exclusion criteria

Exclusion criteria: Antibiotics treatment. Consuming probiotic supplements and/or probiotic-enriched foods. Immunosuppressant treatment before study entry. Infection.

Design outcomes

Primary

Measure	Time frame
Gene expression of Osteoprotegerin. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Gene expression of Receptor Activator of Nuclear Factor Kappa Beta Ligand. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Serum level of osteocalcin. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: ELISA.;Serum level of C- terminal Telopeptide of Type I Collagen. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: ELISA.;Quality of life. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: questionnare.;Anthropometric index(weight, height, and Body Mass Index). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Analogue scale.;Body composition. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Body analyzer.	—

Measure

Time frame

Gene expression of Osteoprotegerin. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Gene expression of Receptor Activator of Nuclear Factor Kappa Beta Ligand. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Serum level of osteocalcin. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: ELISA.;Serum level of C- terminal Telopeptide of Type I Collagen. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: ELISA.;Quality of life. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: questionnare.;Anthropometric index(weight, height, and Body Mass Index). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Analogue scale.;Body composition. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Body analyzer.

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Secondary

Measure	Time frame
Gastrointestinal symptoms. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Hamedi-Kalajahi

Tabriz University of Medical Sciences

fatemehamedi2018@yahoo.com+98 41 3441 7843

Outcome results

None listed

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