フルクタン不耐症の被験者におけるサクロシダーゼとプラセボの効果

実験的：処理

被験者は積極的な治療、サクロシダーゼ、毎食またはスナックで2 mL（17,000 IU）を摂取するように無作為化され、2〜4オンス（60〜120 mL）の水または牛乳（冷または室温）で希釈した後、経口投与されます。治療期間1または治療期間2のいずれかの間。研究治療期間は1週間です。

薬：サクロシダーゼ内用液

治験薬

他の名前：

• サクロシダーゼ

プラセボコンパレーター：プラセボ

被験者は、プラセボ治療、サクロシダーゼ プラセボ、2 mL (17,000 IU) を毎食または間食で摂取するよう無作為に割り付けられ、2 ～ 4 オンス (60 ～ 120 mL) の水または牛乳 (冷水または室温) で希釈した後、経口投与されます。 ) 治療期間 1 または治療期間 2 のいずれかの間。研究治療期間は 1 週間です。

薬：プラセボ

プラセボ

Change From Baseline in Mean (SD) Total Symptom Score (TSS) at 1 Week

The numeric value of the Total Symptom Score (TSS) is derived from the Daily Symptom Questionnaire (DSQ). The DSQ consisted of rating the frequency in the last 24 hours and the severity of 7 symptoms, abdominal bloating, abdominal pain, abdominal cramps, abdominal gas/flatulence, constipation, nausea, and diarrhea. The daily symptom score is calculated by summing the frequency and severity scores for each symptom with a minimum daily score of 0 and a maximum daily score of 98. The TSS is calculated by averaging the combined daily symptom scores during a 7-day period for baseline and 1-week post-intervention during each treatment period and ranges from 0-98, with higher values representing a worse outcome.

Change From Baseline in Mean (SD) Frequency Score for Abdominal Bloating From Baseline to 1 Week

The Daily Symptom Questionnaire (DSQ) consisted of rating the frequency in the last 24 hours and the severity of 7 symptoms, abdominal bloating, abdominal pain, abdominal cramps, abdominal gas/flatulence, constipation, nausea, and diarrhea. The frequency score for abdominal bloating experienced is calculated by averaging the combined daily scores during a 7-day period for baseline and 1-week post-intervention during each treatment period and ranges from 0-5, with higher values representing a worse outcome.