A prospective, randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of DigeSEB Super PB on digestion and gastrointestinal symptoms in healthy adults - Not Applicable

Advanced Enzyme Technologies Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•1 Literate Male and female in equal ratio i e 18 in each group between the age of 30 to 60 years both inclusive
•2 Participants determined by the PI as healthy participants with no known history of any disease or with complaints of any health aliment not prescribed with any medications and indicating good health with normal appetite normal physical and mental conditions
•3 Participants willing to give written informed consent and adhere to all the requirements of this protocol

•1.Pregnant and lactating female.
•2.Participants with BMI = 30
•3.Smokers and people who consume alcohol.
•4.Subject having known allergy to the ingredients in the test product.
•5.Known history of diabetes and hypertension.
•6.Participant having a history of or currently has any gastrointestinal disease or disorder or any inflammatory bowel condition such as Gastroesophageal reflux disease (GERD), Crohn’s disease, short bowel, ulcerative colitis, or irritable bowel syndrome (IBS).
•7.Participant has a history of bariatric surgery at any time before the Screening Visit.
•8.Participant has a history of any surgery in the past 3 months.
•9.Participant has a history of lactose intolerance.
•10.Participant on medications for diarrhea, constipation, heart burn or any other gastrointestinal problems.
•11.Participant currently taking laxatives or has taken laxatives within the 30 days prior to screening/ enrollment.
•12.Participant currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 60 days prior to screening/enrollment.
•13.Participant currently taking or has in the past 30 days used GI related probiotics/prebiotics or any digestive enzymes [prescription or over the counter (OTC)].
•14.As per discretion/ judgement of the PI, subjects suspected with any medical condition during examination at screening

发起方

Advanced Enzyme Technologies Ltd