According to this study:

* Treatment of ulcerative colitis with balsalazide disodium improves rectal bleeding and other symptoms in patients five to 17 years old.

The Food and Drug Administration (FDA) has approved balsalazide disodium (Colazal), already approved for use in adults with mildly to moderately active ulcerative colitis, for treatment in children and adolescents five to 17 years old. About five in 100,000 people in this age group have the condition each year in the United States. The FDA had conferred orphan drug status on balsalazide disodium according to its Orphan Products Development Grants Program, in which applicants are offered financial incentives to develop drug therapies for diseases that affect fewer than 200,000 people each year.

Ulcerative colitis causes inflammation and ulceration in the lining of the rectum and colon; the most common symptoms are abdominal pain and bloody diarrhea sometimes accompanied by anemia, fatigue, loss of weight, rectal bleeding, loss of appetite, loss of bodily fluids and nutrients, skin lesions, joint pain, and failure to grow (in children). Symptoms are mild in about half of patients but more severe in others, who suffer frequent fever, bloody diarrhea, nausea, and severe abdominal cramping. Patients have abnormalities of the immune system, including a possible abnormal reaction to bacteria in the digestive tract, but it's unknown whether that's the cause of the disease or a sequela of it. Despite the many proposed theories, etiology has not been determined.

The drug's safety and efficacy in children were determined in a clinical trial involving 68 patients five to 17 years of age assigned at random to receive either 6.75 g or 2.25 g of balsalazide disodium daily for eight weeks. The researchers found that 45% of those receiving the higher dose and 37% of those receiving the lower dose of balsalazide showed significant improvement in rectal bleeding and an augmented presence of gastrointestinal mucosa. Reported adverse effects include headache, vomiting, diarrhea, and abdominal pain; they were more prevalent in the group taking the lower dose, possibly because of lesser efficacy of the drug.