None listed
Conditions
Interventions
Intervention1: Lactobacillus plantarum UBPL-40: 10 billion CFU lyophilised Lactobacillus plantarum UBPL-40 plus 10 mg iron (Ferrous bisglycinate), 100 µg folic acid, 40 mg ascorbic acid and 1.0 µg vit
Sponsors
Unique Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Young women of reproductive age between 20 to 40 year with normal haemoglobin =12 g/dl and low iron stores (plasma ferritin 2.Subject is willing and able to comply with the protocol and diet 3.Is willing to refrain from using any dietary supplements or nutritionals during the study 4.Not taking any new vitamin and/or mineral supplements for last 3 months
Exclusion criteria
Exclusion criteria: 1.Subjects taking any probiotic products, iron supplementation, or ascorbic acid supplementation during the last 4 weeks prior to the start of the intervention. 2.Subjects having pregnancy or plans for pregnancy within the following 12 weeks. 3.Subject having any medical conditions 4. Subject having a history of or currently has any gastrointestinal disease or disorder or any inflammatory bowel condition such as Cohn’s disease, short bowel, ulcerative colitis, or Irritable Bowel Syndrome (IBS). 5.Subject is lactose intolerant (self-professed or diagnosed). 6.If a subject has had any stomach or intestinal surgery (i.e. gastric bypass). 7.Subject on medications for diarrhea, constipation, heart burn or any other gastrointestinal problems. 8.Subject currently taking laxatives or has taken laxatives within the 30 days prior to screening/ enrollment. 9.Subject currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 60 days prior to screening/enrolment. 10.Subject currently taking or has in the past 30 days used probiotics/prebiotics (including yogurt and lacto-fermented beverages) or any digestive enzymes [prescription or over-the-counter (OTC)]. 11.Subject having known allergy to the ingredients in the test product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum ferritin levelsTimepoint: Baseline, 6 weeks and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.hemoglobin, 2.erythrocyte volume fraction (EVF), 3.serum iron, 4.total iron-binding capacity (TIBC), 5.transferrin saturation, 6.reticulocytes, 7.reticulocytes hemoglobin content (Ret-Hb), 8.hepcidin, 9.soluble transferrein receptor (sTfR) 10.RBC folate and serum vitamin B12 levels Timepoint: baseline, 6 weeks and 12 weeks. | — |
Countries
India
Contacts
Public ContactRamakrishnan Lakshmy
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed