Evaluating the effect of probiotics in patients with myelopathy

Evaluating the effect of probiotics on clinical signs, inflammatory and viral factors in patients with myelopathy secondary to HTLV-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180618040127N2

Enrollment

Registered

2019-01-06

Start date

2019-02-20

Completion date

Unknown

Last updated

2019-01-29

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

Conditions

HAM/TSP patients. Human T-cell lymphotrophic virus, type I [HTLV-I] as the cause of diseases classified elsewhere

Interventions

Intervention 1: Intervention group: Daily administration of two 500-mg capsules of Lacto-Care for 3 months. The Lacto-Capsule is an oral capsule containing the highest levels of beneficial bacteria (l

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: positive serology for HTLV-1 Occurrence of spastic paraparesia Existence of anti HTLV-1 antibody in cerebrospinal fluid Rule out of other etiologies of spastic paraparesia MDG less than 9 Disease duration of less than 15 years Informed consent for participating in the study

Exclusion criteria

Exclusion criteria: Existence of other comorbidities Receiving other drug which influence immune system

Design outcomes

Primary

Measure	Time frame
Medical Research Council (MRC) Scale for Muscle Strength. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination.;Spasticity score with Ashworth scale. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination.;Motor Disability score with Osame Motor Disability Score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination.;Urinary disturbance score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination and medical history.;Serum level of inflammatory cytokines (IL-1, IL-4, IL-6 and IFN-?). Timepoint: At the begging of study and 12 weeks later. Method of measurement: Serum level evaluation.	—

Measure

Time frame

Medical Research Council (MRC) Scale for Muscle Strength. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination.;Spasticity score with Ashworth scale. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination.;Motor Disability score with Osame Motor Disability Score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination.;Urinary disturbance score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination and medical history.;Serum level of inflammatory cytokines (IL-1, IL-4, IL-6 and IFN-?). Timepoint: At the begging of study and 12 weeks later. Method of measurement: Serum level evaluation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Fariba Zemorshidi

Mashhad University of Medical Sciences

zemorshidif@mums.ac.ir+98 51 3840 0000

Outcome results

None listed

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