Kristalose (Lactulose) - Summary

KRISTALOSE SUMMARY

KRISTALOSE™ (LACTULOSE) is a synthetic disaccharide in the form of crystals for reconstitution prior to use for oral administration.

KRISTALOSE™ (LACTULOSE) For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

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NEWS HIGHLIGHTS

Media Articles Related to Kristalose (Lactulose)

Health Tip: Help Control Constipation (HealthDay)
Source: Y! Health Digestive Health News [2009.11.12]
HealthDay - (HealthDay News) -- Constipation occurs when it becomes difficult or painful to have regular bowel movements. What's "regular" varies by person, however.

Health Tip: Help Control Constipation
Source: MedicineNet Constipation Specialty [2009.11.12]
Title: Health Tip: Help Control Constipation
Category: Health News
Created: 11/12/2009 8:10:00 AM
Last Editorial Review: 11/12/2009

Ironwood And Forest Announce Positive Linaclotide Results From Two Pivotal Phase 3 Trials In Patients With Chronic Constipation
Source: Irritable-Bowel Syndrome News From Medical News Today [2009.11.04]
Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of once-daily dosing of the investigational drug linaclotide in patients with chronic constipation (CC).

Health Tip: Help Prevent Your Child's Constipation
Source: MedicineNet Constipation Specialty [2009.09.25]
Title: Health Tip: Help Prevent Your Child's Constipation
Category: Health News
Created: 9/25/2009 8:10:00 AM
Last Editorial Review: 9/25/2009

Health Tip: When Constipation Requires a Doctor's Appointment
Source: MedicineNet Laxatives For Constipation Specialty [2009.08.03]
Title: Health Tip: When Constipation Requires a Doctor's Appointment
Category: Health News
Created: 8/1/2009 7:00:00 AM
Last Editorial Review: 8/3/2009

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Published Studies Related to Kristalose (Lactulose)

Secondary prophylaxis of hepatic encephalopathy: an open-label randomized controlled trial of lactulose versus placebo. [2009.09]
BACKGROUND & AIMS: Hepatic encephalopathy (HE) is associated with a poor prognosis. Lactulose is used for the treatment of HE. There is no study on the prevention of recurrence of HE using lactulose... CONCLUSIONS: Lactulose is effective for prevention of recurrence of HE in patients with cirrhosis.

A dietary fiber mixture versus lactulose in the treatment of childhood constipation: a double-blind randomized controlled trial. [2008.11]
BACKGROUND: Constipation is a common problem in children. As first-line treatment, increased dietary fiber is often advocated. To our knowledge, however, no large studies evaluating the effect of dietary fibers in childhood constipation have been published... CONCLUSIONS: A fluid fiber mixture and lactulose give comparable results in the treatment of childhood constipation.

An open-label randomized controlled trial of lactulose and probiotics in the treatment of minimal hepatic encephalopathy. [2008.06]
BACKGROUND AND AIM: Minimal hepatic encephalopathy (MHE) is associated with poor quality of life and increased work disability. Treatment with lactulose and probiotics has shown some benefit. We compared lactulose with probiotics and a combination of lactulose plus probiotics in the treatment of MHE... CONCLUSION: A total of 55% of the patients with cirrhosis had MHE. Lactulose or probiotics or combinations of both are equally effective in the treatment of MHE.

Effects of therapeutic doses of lactulose vs. polyethylene glycol on isotopic colonic transit. [2008.05]
BACKGROUND: Lactulose and polyethylene glycol are osmotic agents used to treat idiopathic chronic constipation. AIM: To compare the effects of low doses of lactulose and PEG 4000 on transit time measured by scintigraphy in normal subjects... CONCLUSIONS: In healthy subjects, in comparison to PEG 4000, usual therapeutic doses of lactulose significantly accelerate ascending colon emptying. This result supports a stimulating motor effect of colonic fermentation of lactulose.

Laxation of critically ill patients with lactulose or polyethylene glycol: a two-center randomized, double-blind, placebo-controlled trial. [2007.12]
OBJECTIVE: To study whether lactulose or polyethylene glycol is effective to promote defecation in critically ill patients, whether either of the two is superior, and whether the use of enteral laxatives is related to clinical outcome... CONCLUSIONS: Both lactulose and polyethylene glycol are more effective in promoting defecation than placebo. Patients receiving polyethylene glycol had a slightly lower incidence of acute intestinal pseudoobstruction, whereas length of stay was shorter in lactulose-treated patients. Morphine administration was associated with delayed defecation except in the polyethylene glycol-treated group. Irrespective of study medication, early defecation was associated with a shorter length of stay.

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Clinical Trials Related to Kristalose (Lactulose)

Lactulose Supplementation in Premature Infants [Completed]
A pilot study to test the safety of use of lactulose in preterm infants and to preliminary assess the hypothesis that lactulose would support the early growth of Lactobacilli in the stools of premature infants and possibly would also improve nutritional status and decrease NEC and late-onset sepsis.

A Preference Study Comparing Kristalose® and Liquid Lactulose [Not yet recruiting]
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy [Recruiting]
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.

Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures [Terminated]
To demonstrate that lactulose acts as a stool softener, relieving the pain at defecation, improving the number of defecations and regulating the colonic transit time in patients suffering of hemorrhoids or anal fissure. To compare efficacy and quality of life in patients treated either with lactulose or plantago ovate.

Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women [Completed]
This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0. 5 g compared to lactulose placebo 15 ml + vitamin D 400 U + calcium 1 g in bone mass preservation among postmenopausal women.

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