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A randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial to study the effect of Bifidobacterium longum BB536 ingestion on anemia improvement.

A randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial to study the effect of Bifidobacterium longum BB536 ingestion on anemia improvement. - A clinical trial to study the effect of Bifidobacterium longum BB536 ingestion on anemia improvement.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015735
Enrollment
80
Registered
2014-11-21
Start date
2014-11-22
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Anemia

Interventions

Sponsors

Tokyo Healthcare University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) Adult women who are 20 to 65 years old at the time of agreement acquisition (2) Subjects whose Hb levels were less than 13 g/dL by a medical examination of 2014.

Exclusion criteria

Exclusion criteria: (1)Subjects who regularly uses the health foods such as supplements for the purpose of iron medicine or the iron supply. (2)Subjects who have serious disease (liver, kidney, cerebrovascular, endocrine metabolic diseases, infectious diseases that requires notification) needed to notify (3)Subjects receiving treatment or medication for cancer, and subjects with a history of cancer. (4)Subjects who have a history of major surgery of digestive system (5)Subject with irritable bowel syndrome, inflammatory bowel syndrome or gastrointestinal dysfunction (6)Subject who regularly undertakes medication or treatment that affects bowel motion (such as: antibiotics, antiflatulents, laxatives, anti-diarrheal drug) or functional food / nutraceuticals, health supplements (such as: lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber) (7)Subject with a history of allergy to medicine and food (8)Subject who donated: 400 ml whole blood within past 12 weeks or 200 ml whole blood within past 4 weeks or plasma or platelets within past 2 weeks prior to this study (9)Subject who is judged to be ineligible due to subject's background, physical findings, medical examination, physical and clinical examination by principal investigator or sub investigator.

Design outcomes

Primary

MeasureTime frame
hemoglobin, red blood cell, serum ferritin

Secondary

MeasureTime frame
hematocrit, serum transferrin, total iron binding capacity (TIBC), reticular red count, total serum iron, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), transferrin-saturation, defecation frequency, fecal property

Countries

Japan

Contacts

Public ContactProf. Taeko Shimoda

Tokyo Healthcare University Faculty of Healthcare, Division of Medical Nutrition

t-shimoda@thcu.ac.jp03-5799-3711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026