We prospectively will survey 30 nuns from the "Congregazione delle Suore Collegine della Santa Famiglia", Palermo, Italy. The subjects will be recruited between January 2017 and June 2017 and will be examined before and after the diet period (30 days) with ancient grains, undergoing clinical evaluation and blood and feces samples collection. Ancient wheat flours will be administered in open label for 30 days

Gluten Sensitivity

Ancient wheat flours will be administered in open label for 30 days

Ancient wheat flours

Congregazione delle Suore Collegine della Santa Famiglia

Effects of Ancient Grains-based Diet in a Closed Community

Laboratory Values evaluation at baseline and after a 30 days challenge with ancient grains-based diet.

Evaluation of modifications of intestinal microbiota (bacterial flora) by feces samples examination, before and after a 30 days challenge with ancient grains-based diet.

Evaluation of modifications in cytokines production from PBMC, before and after the diet period (30 days) with ancient grains.

Pasquale Mansueto

University of Palermo

Gluten-free diet adding rusks (100g / day) produced with commercial wheat flour enzymatically treated with mTGasi and lysine ethyl ester.

Gluten-free diet adding rusks (100g / day) produced with untreated wheat flour.

Celiac Disease

100 g of rusks obtained from commercial wheat flour enzymatically treated with mTGasi and lysine ethyl ester, every day for 3 months

rusks made of wheat flour enzymatically treated

100 g of rusks obtained from commercial wheat flour NOT enzymatically treated with mTGasi and lysine ethyl ester, every day for 3 months

rusks made of wheat flour not enzimatically modified

Gluten-free diet

Sapienza University - Policlinico Umberto I

Wheat Flour Treatment With Microbial Transglutaminase and Lysine Ethyl Ester: New Frontiers in Celiac Disease Treatment.

Wheat Flour Subjected to Microbial Transglutaminase Enzymatic Treatment in the Presence of Lysine Ethyl Ester for Alimentary Use in the Treatment of Celiac Disease.

Proof of any positivization of specific serological antibodies for celiac disease. Results quantified by an ELISA reader at 450 nm (A450nm) is expressed in U/mL and the antibody level 10 U/mL was used as a cutoff value to identify anti-tTG positive results.

Test used to confirm serological activation of celiac disease. IgA EMA were searched in sera diluted 1:5 by indirect immunofluorescence analysis on cryostat sections of monkey esophagus. The results are expressed as ''positive/negative''.

Proof of duodenal mucosa histological alterations induced by celiac disease, consisting in altered (<3:1) villous height/crypt depth ratio and increased (>25) intraepithelial lymphocytes per 100 intestinal epithelial cells, according to Marsh-Oberhuber classification.

Evaluation of bloating intensity is reported according to the Visual Analog or Analogue Scale (VAS), with a range of 0-10.

Evaluation of abdominal pain intensity is reported according to the Visual Analog or Analogue Scale (VAS), with a range of 0-10.

Evaluation of diarrhea intensity is reported according to the Visual Analog or Analogue Scale (VAS), with a range of 0-10.

Evaluation of asthenia intensity is reported according to the Visual Analog or Analogue Scale (VAS), with a range of 0-10.

Antonio Picarelli

Medical Doctor

University of Roma La Sapienza

Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.

Glucantime® 20 mg /Kg /day for 20 days (intramuscular)

One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.

Miltefosine

Glucantime®

Thermotherapy

Total

Sex: Female, Male

Region of Enrollment

Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment.
Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment.

Complete Clinical Response

Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up.

Recurrence

At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment

glutamic/diarré

Effects of Ancient Grains-based Diet in a Closed Community

Wheat Flour Treatment With Microbial Transglutaminase and Lysine Ethyl Ester: New Frontiers in Celiac Disease Treatment.

Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.

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