Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-Blind, Placebo Controlled, Crossover Trial On The Efficacy Of A Mixture Of Three Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders
Brief Summary: Abdominal pain (AP)-associated functional gastrointestinal disorders (FGIDs), particularly Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), are common in pediatrics, and no safe and effective treatment is available. Although probiotics have shown promising results in adults, few studies have been published in children. The Bifidobacterium Infantis, Bifidobacterium Breve and Bifidobacterium Longum are the most important beneficial bacteria in children and represent 95% of the total bacterial population in the intestine of breastfed infant.

Objectives: 1) To evaluate the effect of oral administration of a mixture of Bifidobacteria on the improvement of frequency and intensity of AP in children with FD and IBS. 2) To evaluate the effect of oral administration of a mixture of Bifidobacteria on quality of life in children with FD and IBS.


Options:
A: Inclusion Criteria:

* Patients were considered for study inclusion, if they were 4 - 12 years of age and had if they had a pain history of at least 12 weeks (which need not be consecutive) in the preceding 12 months suggestive for IBS or FAP with no structural or metabolic abnormalities to explain the symptoms and according to the Rome II diagnostic criteria valid at the time of the design of the study.
* IBS was diagnosed in presence of an abdominal discomfort or pain with at least two of three features:

  * relieved with defecation
  * onset associated with a change in stool frequency
  * onset associated with a change in the form (appearance) of the stool.
* FAP was diagnosed in presence of symptoms of
* Continuous (nearly continuous) abdominal pain
* No or only occasional relation of pain with physiological events (e.g. eating, menses)
* Some loss of daily functioning
* The pain is not feigned (e.g. malingering)
* The patient has insufficient criteria for other functional gastrointestinal disorders that would explain the abdominal pain.

Exclusion Criteria:

* Known concomitant psychiatric, neurological, metabolic, hepatic, renal, infectious, haematological, cardiovascular and pulmonary disease
* Treatment with antibiotics/probiotics in the last 2 months
* A pain history suggestive for functional dyspepsia or aerophagia or abdominal migrain
* Growth failure
* Gastroparesis
* Gastrointestinal obstructions/stricture
* Any disease that may affect bowel motility such as diabetes, connective disease or poorly controlled hypo/hyperthyrodism
* Previous abdominal surgery.
B: Inclusion Criteria:

* Age 4-18years;
* Diagnosis of FD and IBS pain according to the Rome III criteria
* All parents or legal tutors must sign an informed consent document indicating their awareness of the investigational nature of this study.

Exclusion Criteria:

* Taking any other type of probiotic in the 2 months prior to enrollment
* Presence of intestinal motility disorders
* Presence of any other significant medical condition
* Presence of previous abdominal surgery
* Inability or unwillingness to give informed consent
C: Inclusion Criteria:

Must include all of the following:

1. Children between the ages of 7-17 years;
2. Meet the criteria for IBS based on the Questionnaire on Pediatric Gastrointestinal Symptoms Rome III Version, including pain/discomfort a minimum of twice per week;
3. Negative physician evaluation for an organic etiology of the pain within the past year

Exclusion Criteria:

Will include any of the following:

1. Diabetes or other disease process requiring specialized dietary management;
2. Malnutrition or obesity (BMI \>95%);
3. Inability to eat by mouth;
4. Antibiotic or medicinal probiotic usage within the past 3 months (excluding yogurt);
5. Neuromodulator (e.g. amitriptyline) usage within the past 3 months
6. Start of, or change in gastrointestinal medication (e.g. laxative) dose that may cause or ameliorate abdominal symptoms within the past month
D: Inclusion Criteria:

* Children who have had at least one physician visit in the past year for abdominal pain or IBS symptoms.
* Children with recurrent abdominal pain who meet the criteria for irritable bowel syndrome.

Exclusion Criteria:

* Children who have another disease that accounts for stomach pain
* Current use of anti-inflammatory medication
* Children taking a GI medication that makes pain go away completely
* Children with other chronic conditions including chronic pain conditions (e.g. heart condition, diabetes)
* Children who have decreased growth
* GI blood loss
* Unexplained fever
* Chronic severe diarrhea
* Weight loss of \> or = to 5% of body weight within 3 month prior to enrollment
* History of abdominal surgeries
* A history of suicide
* Cognitive impairment significantly below average age and/or grade level
* Non-English speaking parent or child
* Vomiting \>2x/month
* Children currently in psychotherapy for abdominal pain.

Answer: B