Intestinal Health and Blood Lipid Adjustment
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      This was a randomized, double-blind, single-center, placebo-controlled, two-arm study. The
      objectives of this study were to evaluate the effect of Momchilovtsi yogurt on:

        1. Improving intestinal digestion and bowl movement;

        2. Adjusting blood total Cholesterol and Triglycerides levels;

        3. Adjusting microbiological flora (Clostridium perfringens bacteria, Lactobacillus and
           Bifidobacterium) in gastrointestinal tract;

        4. Adjusting short chain fatty acids (acetic acid, propionic acid, butyric acid) in in
           gastrointestinal tract.
    

Detailed description: 
      1. Quality control of the study:

           1.1 Study monitoring and source data verification:

           Monitoring was done according to the monitoring plan by a representative of the
           investigator, who checked the case report forms for completeness and clarity, and
           cross-checked them with source documents. In addition to the monitoring visits, frequent
           communications (letter, telephone, fax, e-mail), by the study monitor ensured that the
           investigation was conducted according to protocol design and regulatory requirements.
           Study close-out was performed by the study monitor upon closure of the study.

           1.2 On-site audits:

           Domestic and foreign regulatory authorities, the Institutional Review Board, and an
           auditor authorized by the sponsor may request access to all source documents, case
           report forms, and other study documentation for on-site audit or inspection. Direct
           access to these documents was guaranteed by the investigator, who must provide support
           at all times for these activities. Medical records and other study documents may be
           copied during audit or inspection provided that subject names are obliterated on the
           copies to ensure confidentiality.

           1.3 Documentation:

           A case report form was provided for each subject.

           All protocol-required information collected during the study was entered by the
           investigator, or designated representative, in the case report form. Details of case
           report form completion and correction were explained to the investigator.

           The investigator, or designated representative, should complete the case report form
           pages as soon as possible after information is collected, preferably on the same day
           that a study patient is seen for an examination, treatment, or any other study
           procedure. Any outstanding entries must be completed immediately after the final
           examination. An explanation should be given for all missing data.

           A source data location list was prepared prior to study initiation. This list was filed
           in both the trial master file and the investigator study file and updated as necessary.

           The completed case report forms were reviewed and signed by the investigator named in
           the clinical study protocol or by a designated sub investigator.

           The sponsor would retain the original of all completed case report forms. The principal
           investigator kept the copies of all completed case report forms for 25 years after the
           trial based on Good Clinical Practice requirements.

        2. Quality assurance of study products:

           All products used in this study were manufactured and provided by Bright Dairy & Food
           Co., Ltd. The quality test of study products was conducted by Shanghai dairy products
           quality supervision and inspection station. The study products were stored at the study
           site and assigned to the subjects by the investigator. The amount of products received
           and assigned were filed on product distribution list by the investigator. The study
           products were not allowed to be given to anyone who didn't participated in the study. No
           sales of unassigned products was allowed. After the completion of the study, the
           unassigned products need to be returned to Bright Dairy & Food Co., Ltd.

           The products were labeled with study code. A master participation list was completed
           which identifies each patient full name and unique identification number. The identity
           of the specific product was blind to patients, support staff and investigators. The
           unmasking occurred to the investigators and statistical analyses team only after
           completion of statistical analyses.

        3. Data management:

           Study data were recorded on Case Report Forms (CRFs) and then entered into saved in the
           form of Excel files. Data was double entered and cross-validated.

        4. Management of subject withdrawal:

           A number of 120 subjects were enrolled in the study.

           Subjects may be withdrawn from the study for the following reasons:

             -  At their own request or at the request of their legally authorized representative,

             -  If, in the investigator's opinion, continuation in the study would be detrimental
                to the patient's well-being,

             -  If they are lost to follow-up.

           In all cases, the reason for and date of withdrawal must be recorded in the Exit Form
           and in the subject's medical records and the sponsor's representative must be notified
           within 5 days. The subject must be followed up to establish whether the reason was an
           adverse event, and, if so, this must be reported in accordance with the procedure of an
           adverse event (described bellow). The investigator must make every effort to contact
           subject lost to follow-up. Attempts to contact such subject must be documented in the
           subject's records (e.g., dates and times of attempted telephone contact).

           Investigator must be notified of all serious or unexpected adverse events within 48
           hours. Notification does not depend on whether there is a connection to the study
           formula or not. All adverse events must be documented on the appropriate pages of the
           case report forms.

        5. Statistical analysis plan:

      Analysis was performed for the intent-to-treat population.

      Chi-square test was used comparison between study groups for categorical data. For continuous
      outcomes, t-test was used for between-group comparison, paired t-test was used for pre-post
      comparison within each study group.3. Non-parametric methods were used for non-normal data,
      data with unequal variances. The analysis was completed using the statistical package
      SPSS17.0.
    

Intervention name(s): Bright Momchilovtsi Yogurt; Bright Dairy Beverage
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral consumption of Bright Momchilovtis Yogurt containing 1×106cfu/g prebiotics including Lactobacillus bulgaricus and Streptococcus thermophilus
Dosage: 110g at a time, twice per day at 10 am and 4 pm. Duration: 7 weeks (March 10, 2013 - April 27, 2013) The active study product has similar package and taste as the placebo.; Oral consumption of Bright Dairy Beverage Dosage: 110g at a time, twice per day at 10 am and 4 pm. Duration: 7 weeks (March 10, 2013 - April 27, 2013) The active study product has similar package and taste as the placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Intestinal Health; Prebiotics; Blood Lipid