Probiotic saccharomyces boulardi in knee osteoarthritis

The effect of probiotic saccharomyces boulardi on anthropometric indecies, functional status, pain and quality of life and serum indices of inflammation and oxidative stress in overweight and obese patients with knee osteoarthritis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20161022030424N4

Enrollment

Registered

2019-09-02

Start date

2019-09-23

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Knee osteoarthritis. Osteoarthritis, unspecified site

Interventions

Intervention 1: Intervention group: The intervention group will take BioDigest capsules once daily for 12 weeks. Each capsule contains 250?mg of SB (1010?CFU) plus a lactose filler and a magnesium ste

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with knee osteoarthritis according to the diagnostic criteria of American College of Rheumatology Being 40 years of age or older Chronic knee pain for the last 3 months Radiologic confirmation of knee osteoarthritis (Kellgren–Lawrence grade II or III ) Body mass index in the range of 25 to 40 kg/m2

Exclusion criteria

Exclusion criteria: Previous knee surgery Rheumatoid arthritis Metabolic disorder (such as diabetes and cancer) Liver or kidney failure Use of corticosteroids and/or intra-articular injections during the preceding 3 months Use of fish oils and glucosamine Participation in a weight loss program in the preceding 6 months Unable to express their pain (such as those with any mental condition)

Design outcomes

Primary

Measure	Time frame
Weight. Timepoint: Weight measurement at baseline (before intervention) and 6 and 12 weeks after intervention. Method of measurement: Seca 813 bt digital scale.;Functional status. Timepoint: Functional status evaluation at baseline (before intervention) and 6 and 12 weeks after intervention. Method of measurement: Western Ontario and McMaster (WOMAC) Index.;Pain intensity. Timepoint: Pain intensity measurement at baseline (before intervention) and 6 and 12 weeks after intervention. Method of measurement: Visual Analogue Scale.;Quality of life. Timepoint: Quality of life evaluation at baseline (before intervention) and 12 weeks after intervention. Method of measurement: 36-Item Short Form Survey (SF-36).;Inflammatory indices. Timepoint: Inflammatory indices measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods.;Oxidative stress indices. Timepoint: Oxidative stress indices measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods.	—

Measure

Time frame

Weight. Timepoint: Weight measurement at baseline (before intervention) and 6 and 12 weeks after intervention. Method of measurement: Seca 813 bt digital scale.;Functional status. Timepoint: Functional status evaluation at baseline (before intervention) and 6 and 12 weeks after intervention. Method of measurement: Western Ontario and McMaster (WOMAC) Index.;Pain intensity. Timepoint: Pain intensity measurement at baseline (before intervention) and 6 and 12 weeks after intervention. Method of measurement: Visual Analogue Scale.;Quality of life. Timepoint: Quality of life evaluation at baseline (before intervention) and 12 weeks after intervention. Method of measurement: 36-Item Short Form Survey (SF-36).;Inflammatory indices. Timepoint: Inflammatory indices measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods.;Oxidative stress indices. Timepoint: Oxidative stress indices measurement at baseline (before intervention) and 12 weeks after intervention. Method of measurement: Biochemical methods.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Dolatkhah

Tabriz University of Medical Sciences

neda_dolatkhah@yahoo.com+98 41 3336 1928

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026