A study to evaluate the effects of Biofermin tablets on bowel management in elderly patients requiring long-term care

JRCT ID: jRCTs031210287

Registered date:30/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Constipation
• Date of first enrollment: 30/08/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Administration of BIOFERMIN tablets

Outcome(s)

• Primary Outcome: Changes in the number of spontaneous bowel movements before and six weeks after starting the treatment.

Secondary Outcome

Changes in fecal properties over time at each evaluation point.
Changes of the total number of defecations over time at each evaluation point.
Changes of the number of spontaneous bowel movements over time before starting the administration, at six weeks and 8 weeks after starting the treatment.
Changes of the number of uses of additional laxatives over time at each evaluation point.
Changes of the number of defecation treatments(suppositories, enemas, disimpaction)over time each evaluation point.
Changes of defecation days over time at each evaluation point.
Changes in intestinal flora over time at each evaluation point.
Changes in organic acids in feces over time at each evaluation point.
Changes in vital signs over time at each evaluation point.
Changes in frequency of fever over time at each evaluation point.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The elderly over 65 years old.
Patients who cannot defecate by themselves,requiring defecation assistance.
Patients who can take nutrition and drugs orally or by tube at the time of enrollment.
Patients who have less than 3 spontaneous bowel movements per week during the pre-observation period.
Patients who receive defecation treatment or additional laxatives at least once a week during the pre-observation period.
Patients who can provide the written consent for participation in this study. However,if the consent cannot be obtained by the patient,it is possible to obtain consent from a legally acceptable representative.

Exclude criteria

Patients who have been pointed out to have organic abnormalities in the digestive tract.
Patients with serious complications.
Patients with infectious diseases.
Patients with active malignant tumors.
Patients who are allergic to intestinal medicine.
Patients who took probiotic products within two weeks before enrollment.
Patients who took opioid analgesics within two weeks before enrollment.
Patients who have been using psychiatric drugs for the treatment of psychiatric disorders, except for the use of sleeping pills or psychotropic drugs as needed.
Patients who took antibacterial agents within two weeks before enrollment.
Patients who started the new drug administration within two weeks before enrollment.
Patients who are inadequate to be enrolled in the study judged by the investigator.

Related Information

• Primary Sponsor: Maruyama Michio
• Source(s) of Monetary Support: Biofermin pharmaceutical CO.,LTD