This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
- Status
- Accepting Candidates
- Ages
- 18 Years - N/A
- Sexes
- All
Pica is a pattern of eating non-food materials, such as dirt or paper.
Geophagy; Lead poisoning - pica
Pica is seen more in young children than adults. Up to one third of children ages 1 to 6 years have these eating behaviors. It is unclear how many children with pica intentionally consume dirt (geophagy).
Pica can also occur during pregnancy. In some cases, a lack of certain nutrients, such as iron and zinc, may trigger the unusual cravings. Pica may also occur in adults who crave a certain texture in their mouth.
Children and adults with pica may eat:
This pattern of eating must last for at least 1 month to fit the diagnosis of pica.
Depending on what is being eaten and how much, symptoms of other problems may be present, such as:
There is no single test for pica. Because pica can occur in people who have poor nutrition, the health care provider may test blood levels of iron and zinc.
Blood tests can also be done to test for anemia. Lead levels should always be checked in children who may have eaten paint or objects covered in lead paint dust to screen for lead poisoning.
The provider may also test for infection if the person has been eating contaminated soil or animal waste.
Treatment should first address any missing nutrients or other medical problems, such as lead poisoning.
Treating pica involves behaviors, the environment, and family education. One form of treatment associates the pica behavior with negative consequences or punishment (mild aversion therapy). Then the person gets rewarded for eating normal foods.
Medicines may help reduce the abnormal eating behavior if pica is part of a developmental disorder such as intellectual disability.
Treatment success varies. In many cases, the disorder lasts several months and then disappears on its own. In some cases, it may continue into the teen years or adulthood, especially when it occurs with developmental disorders.
Complications include:
Contact your provider if you notice that a child (or adult) is eating nonfood materials.
There is no specific prevention. Getting adequate nutrition may help.
Camaschella C. Microcytic and hypochromic anemias. In: Goldman L, Schafer AI, eds. Goldman-Cecil Medicine. 26th ed. Philadelphia, PA: Elsevier; 2020:chap 150.
Katzman DK, Norris ML. Feeding and eating disorders. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease: Pathophysiology/Diagnosis/Management. 11th ed. Philadelphia, PA: Elsevier; 2021:chap 9.
Kliegman RM, St. Geme JW, Blum NJ, Shah SS, Tasker RC, Wilson KM. Rumination and pica. In: Kliegman RM, St. Geme JW, Blum NJ, Shah SS, Tasker RC, Wilson KM, eds. Nelson Textbook of Pediatrics. 21st ed. Philadelphia, PA: Elsevier; 2020:chap 36.
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This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
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