Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax).

Subjects will follow a sham diet and will take PEG 3350 (Miralax).

Irritable Bowel Syndrome Characterized by Constipation

Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.

Low FODMAP diet/PEG 3350

Subjects will follow a sham diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.

sham diet/PEG 3350

University of Michigan

Low FODMAP Plus PEG 3350 for the Treatment of Patients With Irritable Bowel Syndrome-Constipation

Compare the proportion of patients with IBS-C on a diet of low FODMAP diet plus PEG 3350 vs. sham diet plus PEG 3350 reporting an improvement of abdominal pain. It is defined 30% reduction in abdominal pain during weeks 3 & 4 of each diet compared with baseline using an 11-point numerical rating scale (NRS) (0-no pain, 11-intolerable pain). Appropriate between-group statistical comparisons will be conducted.

The change in mean score from baseline on the daily 11-point NRS averaged over each treatment week for bloating severity will be compared between the 2 groups.

30% reduction in abdominal discomfort during weeks 3 & 4 of each diet compared with baseline using an 11-point NRS. Appropriate between-group statistical comparisons will be conducted.

These will be measured in the last treatment week (the 7-day period before visit 4): The proportion of responders between the 2 groups will be compared. An SBM was defined as a bowel movement that occurred without the use of rescue medication or ≥24 h after the use of rescue medication.

These will be tallied in the last treatment week (the 7-day period before visit 4):(SCBMs; derived from the number of SBMs without a feeling of incomplete evacuation)

a responder will be defined as one who reports an increase in mean daily BSFS value of 1 or more compared to baseline for ≥2 of 4 treatment weeks. The proportion of responders between the 2 groups will be compared. Between group differences in the proportion of patients with an increase in BSFS value of ≥1

The change from baseline in daily numerical rating scale scored as 0 (none), 1 (slight), 2 (mild), 3 (moderate) and 4 (severe) scores averaged over each treatment week for straining will be compared between the 2 groups

assess change in IBS-QOL from baseline and the last week of treatment week 4

assess change in HADS score from baseline and the last week of treatment of week 4

assess change in WPAI questionnaire from baseline and the last week of treatment of week 4

assess change in Sleep Assessment questionnaire from baseline and the last week of treatment of week 4

Stacy Menees

Assistant Professor

Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt

Yogurt without Bifidobacterium animalis subsp. lactis BB-12

Antibiotic-associated Diarrhea

Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt

Bifidobacterium animalis subsp. lactis BB-12

Control

Georgetown University Department of Family Medicine, Research Division

Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics

Diarrhea is clinically defined as three or more loose stools per day for two consecutive days. This will be a dichotomous (yes or no) outcome of diarrhea.

The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory

This will be a dichotomous (yes or no) outcome of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat.

Daniel Merenstein

Professor and Director of Research Programs

Georgetown University

University of Maryland, Baltimore

Penn State University

Probiotic, Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12), supplemented strawberry yogurt, 4 ounces taken orally for 10 days

Placebo, strawberry yogurt, 4 ounces taken orally for 10 days

Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt

BB-12®

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Child Attends Daycare

Parent's Marital Status

Total Household Income

Smoker in Household-Yes

The primary outcome is to assess the safety of BB-12® yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time.

Number of Adverse Events

The secondary aim was to evaluate the influence of BB-12®-supplemented yogurt and control yogurt on the fecal microbiota of participants and determine any changes in the composition of the microbial community.

Changes in Composition of the Microbial Community

BB-12

Overall Study

Director of Research Programs

Children

Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days

BB-12 supplemented strawberry yogurt

Strawberry flavored yogurt

Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children

Yogurt Beverages as a Vehicle to Deliver High Dose Probiotics

Principal Investigator

Blood, throat swab, nasopharyngeal aspiration, and rectal swab will be obtained during acute illness and at convalescence (about 2 weeks after discharge). These specimens will be processed for viral isolation, bacterial culture and toxin detection, PCR, subtractive cloning, VIDISCA, gene chips, peptide library, cytokine/chemokine measurement, antibody detection for specific pathogens, etc. Questionnaire for contact history and clinical symptoms will be performed.

Kawasaki Disease

National Taiwan University Hospital

Etiology Study of Kawasaki Disease

Etiology Study of Kawasaki Disease--A Prospective Household and Case Control Study

The mean age of the 226 KD cases was 2.07 years, and the male to female ratio was 1.43 (133 boys to 93 girls). Their mean fever duration was 7.5 days with a mean peak temperature of 39.7°C. In addition to the typical symptoms of fever, neck lymphadenopathy, lip fissure and/or strawberry tongue, skin rash, nonpurulent bulbar conjunctivitis, palm/sole erythema, and induration followed by periungual desquamation, these KD cases also exhibited cough (69%), rhinorrhea (58%), and diarrhea (45%). Cases of KD had a significantly higher positive rate of viral isolation in comparison with the control group (7.5% vs. 2.2%, p = 0.02). Compared with the control group, cases of KD were more likely to have overall positive rates of viral PCR (50.4% vs. 16.4%, p < 0.001) and for various viruses including enterovirus (16.8% vs. 4.4%, p < 0.001), adenovirus (8.0% vs. 1.8%, p = 0.007), human rhinovirus (26.5% vs. 9.7%, p < 0.001), and coronavirus (7.1% vs. 0.9%, p = 0.003).

sweet potato/diarree

Low FODMAP Plus PEG 3350 for the Treatment of Patients With Irritable Bowel Syndrome-Constipation

Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics

Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children

Etiology Study of Kawasaki Disease

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