Abstract | OBJECTIVE: DESIGN: A parallel-group, double-blind, randomized, placebo-controlled trial. SETTING: Patients at home, recruited through out-patient contact, social media and patient support groups. SUBJECTS: INTERVENTIONS: All participants took one capsule of oral OM-89 immunotherapy (6 mg) or matching Placebo (randomisation ratio 1:1), once daily in the morning for 3 months. MAIN MEASURES: The primary outcome was occurrence of a symptomatic urinary tract infection treated with an antibiotic, assessed at 3 and 6 months. Feasibility measures included recruitment, retention and practical difficulties. RESULTS: Of 115 patients screened, 49 were recruited, one withdrew before randomization, and 23 were allocated to the control group receiving matching placebo. Six participants, all in the control group, discontinued the intervention; all participants provided full data at both follow-up times. Over 6 months, 18/25 active group patients had 55 infections, and 18/23 control group patients had 47 infections. Most research and clinical procedures were practical, and acceptable to participants. CONCLUSION: It is feasible to undertake a larger trial. We recommend broader inclusion criteria to increase eligibility and generalizability.
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Authors | Derick T Wade, James Cooper, Nicholas Peckham, Maurizio Belci |
Journal | Clinical rehabilitation
(Clin Rehabil)
Vol. 34
Issue 12
Pg. 1458-1464
(Dec 2020)
ISSN: 1477-0873 [Electronic] England |
PMID | 32762340
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Adjuvants, Immunologic
- Anti-Infective Agents, Urinary
- Antigens, Bacterial
- OM 89
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Topics |
- Adjuvants, Immunologic
(therapeutic use)
- Anti-Infective Agents, Urinary
(therapeutic use)
- Antigens, Bacterial
- Cauda Equina Syndrome
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Multiple Sclerosis
- Myelitis, Transverse
- Pilot Projects
- Spinal Cord Injuries
- Urinary Bladder, Neurogenic
(complications, etiology)
- Urinary Tract Infections
(prevention & control)
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