Health Condition 1: null- Irritable Bowel Syndrome in children
Conditions
Interventions
Intervention1: VSL#3 sachets (450 billion CFU/sachet): 4-10 years (17-33 kg): 1 packet/day orally
11-17 years: 2 packets/day orally
Control Intervention1: Placebo sachets (corn starch): â?¢ 4-10 years
Sponsors
CD Pharma India Pvt LtdC first FloorSDA New DelhiTel
Eligibility
Inclusion criteria
Inclusion criteria: • The subject or his/her legal guardian signs and dates a written informed consent form prior to the initiation of any study related activities. • The subject is at least 4 and no older than 18 years old, male or female. • The subject is complaining of IBS symptoms for at least 3 months â?? not necessarily consecutive â?? over the previous 12 months and meets the Rome II criteria listed below: In children old enough to provide an accurate pain history, at least 12 weeks, which need not be consecutive, in the preceding 12 months of: (1) Abdominal discomfort or pain that has two out of three features: a) Relieved with defecation; and/or b) Onset associated with a change in frequency of stool; and/or c) Onset associated with a change in form (appearance) of stool; and (2) There are no structural or metabolic abnormalities to explain the symptoms.
Exclusion criteria
Exclusion criteria: 1) Subject who has been diagnosed with any of the following GI disorders: - Inflammatory bowel disease (Crohnâ??s disease, Ulcerative colitis, Indeterminate Colitis) - Microscopic colitis (lymphocytic colitis, collagenous colitis) - Celiac Disease - Gastroparesis - Gastrointestinal obstruction and/or stricture - Chronic pancreatitis - Any disease that may affect bowel motility such as diabetes mellitus, sarcoidosis, connective tissue disease, or poorly controlled hypo/hyperthyroidism. 2) Subject who has undergone previous abdominal surgery (with the exception of uncomplicated appendectomy or cholecystectomy 6 months prior to enrollment) 3) Subject with a significant concomitant psychiatric, neurological, metabolic, renal, hepatic, infectious, hematological, cardiovascular or pulmonary illness, unless condition is stable and judged by the investigator not to interfere with the patientâ??s participation in the study 4) Subject taking at the time of proposed enrolment any of the below listed prohibited medications: - Anticholinergics (dicyclomine, hyoscyamine, propantheline)  Cholinomimetic agents (bethanechol, etc.)  All narcotics (morphine, codeine, propoxyphene either alone or in any combination)  5-HT3 receptor antagonists (e.g., alosetron, ondansetron, tropisetron, dolasetron, granisetron).  Gastrointestinal preparations:  Antacids (containing either magnesium or aluminium)  Antidiarrheal agents  Bismuth compounds  Laxatives (stimulant or osmotic)  Sulfasalazine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global relief from symptoms of IBS. This parameter will be evaluated utilizing the Subjectâ??s Global Assessment of Relief for Children (SGARC), at baseline and at all subsequent visits. The primary efficacy endpoint will be the proportions IBS global improvement scale responders at week 6. Subjectâ??s Global Assessment of Relief for Children with IBS (SGARC)* The child/caregiver will be asked to answer the following question: Consider how your child felt this past week in regard to their IBS, especially the overall well-being, symptoms of abdominal discomfort, pain and altered bowel habits. Compared to the way he/she usually felt before entering the study, how do you rate the relief of symptoms during the past week? (1) Complete relief (2) Considerable relief (3) Somewhat relieved (4) Unchanged (5) Worse (Adapted from Muller-Lissner et al [9]) * This question will be answered by the parent and child if the child is younger than 12 years old. Timepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal pain/discomfort; number of daily stools; consistency of daily stools; abdominal bloating/gassiness (for subjects 12-18 years of age). 1) Functional Disability Inventory (FDI) â?? A surrogate marker for QoL Parent and child forms (Form 2A and 2B) of this validated instrument will be completed at day 1, day 57, day 71, and day 113 of the trial. In addition the parent will document daily whether their child was unable to participate in normal activities due to pain. 2) Abdominal pain/Discomfort Parents and children will document the daily pain as follows: a. The children will record their pain according to the Faces Pain Scale- Revised (FPS-R) [12] daily at 7 am, 2 pm, and 6 pm daily. b. The parents will report the childâ??s pain through the use of verbal/behavioral cues (crying, grimacing, sighing) at 7 am, 2 pm, and 6 pm daily. c. The parents will use the FPS-R to document the intensity of the worse abdominal pain observed in the child that day. 3) Bloating/gassiness Parents and children will document the daily intensity of bloating using a six point scale from 0-5 (indicating none to very severe). 4) Stool Pattern Parents and children will document the daily bowel movements (BMâ??s) as follows: a. Number of daily BMâ??s b. Average consistency of stools according to the stool consistency scale [13]: 1) Watery 2) Loose 3) somewhat loose 4) neither loose nor hard 5) somewhat hard 6) hard 7) very hard Timepoint: Data obtained and analysed for all through the study and comparing the cross-over details | — |
Countries
India
Contacts
Public ContactDr Sarath Gopalan
Indraprastha Apollo Hospital
Outcome results
None listed