The goal of this interventional study is to evaluate the effectiveness of Notrande Shuhuajun Probiotic Supplement intake on the improvement of functional constipation in preschool children (3-6 years old). The main questions it aims to answer are: \- Does Notrande Shuhuajun Probiotic Supplement intake improve functional constipation in preschool children? 105 eligible participants will be enrolled in one center and assigned the study product. After one week washout period participants need to take in the product for two weeks, followed by a one-week regression period. Researchers will collect data, analyze data and conclude whether the study product is effective to improve constipation in participants, by comparing the change of concentration of biochemical indicators SCFA (Short-chain fatty acids), Lactobacillus and Bifidobacterium, and visual analysis of Bristol Stool scale etc..
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
102
Participants in this arm need to take in the assigned product - Notrande Shuhuajun Probiotic Supplement, 1 capsule per day, for 14 consecutive days. Don't take in similar products in the following 7 days (regression phase).
Fuyang Fifth People's Hospital Quanying Branch
Fuyang, Anhui, China
Change of constipation indicators-SCFA (Short-chain fatty acids) level in the fecal samples
Change of constipation indicators: SCFA (Short-chain fatty acids) level in the fecal samples, from baseline day 0, to day 14, and to end day 21. unit: mg/100g fecal sample, higher level means improved constipation.
Time frame: day 0, day 14, and day 21
Change of constipation indicators- Probiotics - Lactobacillus and Bifidobacterium concentration level in the fecal samples
Change of constipation indicators: Probiotics - Lactobacillus and Bifidobacterium concentration level via qPCR in the fecal samples, from baseline day 0, to day 14, and to end day 21. unit: CFU/g, higher level means improved constipation.
Time frame: day 0, day 14, and day 21
Change of Bristol Stool Form Scale (BSFS)
Change of Bristol Stool Form Scale (BSFS) by visual judgement of look and form of participants' bowel movements, type 1 to type 7, mapping to score 1 to 7, the smaller value indicates improved constipation.
Time frame: day 0 , day 21
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