The effect of Probiotic formulation on iron absorption in iron deficient women of reproductive age: a double-blind, randomized placebo-controlled trial

nique Biotech Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1.Young women of reproductive age between 20 to 40 year with normal haemoglobin =12 g/dl and low iron stores (plasma ferritin <30 ng/ml and high-sensitive C-reactive protein (hsCRP) =5 mg/L.
•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

•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.

发起方

nique Biotech Pvt Ltd