CLINICAL TRIALS PROFILE FOR LACTITOL

All Clinical Trials for Lactitol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00839358 ↗	Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation	Completed	Hospital Universitari de Bellvitge	Phase 4	2008-08-01	The aim of this study is to evaluate the effect of prolonged administration of albumin and midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver transplantation will include in the study. Patients will be randomized to receive albumin and midodrine (treatment group) or administration of placebo (saline for albumine) and tablets with excipients without midodrine (control group). Patients will be followed-up during 12th months. In the treatment group albumin will be given at a dose of 40g every 15 days and midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment that patients require by cirrhosis. The group control will receive placebo in the same way than the treatment group in addition with lactitol and the specific treatment that they require by their disease. In all the patients liver and renal function test, hormones determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months. Before the inclusion in the study neuropsychological test and critical flicker test will be performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months. All the determinations will be repeated at any time that the patients develop any complication considered as an end point. In baseline conditions and at 3rd and 6th months a questionnaire of quality of life (SF36) will be performed. During a year of follow-up the number of paracentesis that patients require, the incidence of renal failure and EH and their relationship with hormonal activity and cytokine levels, free transplant survival and quality of life will be recorded.
NCT00839358 ↗	Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation	Completed	Maternal-Infantil Vall d´Hebron Hospital	Phase 4	2008-08-01	The aim of this study is to evaluate the effect of prolonged administration of albumin and midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver transplantation will include in the study. Patients will be randomized to receive albumin and midodrine (treatment group) or administration of placebo (saline for albumine) and tablets with excipients without midodrine (control group). Patients will be followed-up during 12th months. In the treatment group albumin will be given at a dose of 40g every 15 days and midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment that patients require by cirrhosis. The group control will receive placebo in the same way than the treatment group in addition with lactitol and the specific treatment that they require by their disease. In all the patients liver and renal function test, hormones determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months. Before the inclusion in the study neuropsychological test and critical flicker test will be performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months. All the determinations will be repeated at any time that the patients develop any complication considered as an end point. In baseline conditions and at 3rd and 6th months a questionnaire of quality of life (SF36) will be performed. During a year of follow-up the number of paracentesis that patients require, the incidence of renal failure and EH and their relationship with hormonal activity and cytokine levels, free transplant survival and quality of life will be recorded.
NCT00839358 ↗	Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation	Completed	Hospital Clinic of Barcelona	Phase 4	2008-08-01	The aim of this study is to evaluate the effect of prolonged administration of albumin and midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver transplantation will include in the study. Patients will be randomized to receive albumin and midodrine (treatment group) or administration of placebo (saline for albumine) and tablets with excipients without midodrine (control group). Patients will be followed-up during 12th months. In the treatment group albumin will be given at a dose of 40g every 15 days and midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment that patients require by cirrhosis. The group control will receive placebo in the same way than the treatment group in addition with lactitol and the specific treatment that they require by their disease. In all the patients liver and renal function test, hormones determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months. Before the inclusion in the study neuropsychological test and critical flicker test will be performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months. All the determinations will be repeated at any time that the patients develop any complication considered as an end point. In baseline conditions and at 3rd and 6th months a questionnaire of quality of life (SF36) will be performed. During a year of follow-up the number of paracentesis that patients require, the incidence of renal failure and EH and their relationship with hormonal activity and cytokine levels, free transplant survival and quality of life will be recorded.
NCT01178372 ↗	Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis	Unknown status	Govind Ballabh Pant Hospital	Phase 4	2008-09-01	Hepatic encephalopathy (HE), a challenging complication of advanced liver disease, occurs in approximately 30-45% of patients with cirrhosis. The treatment of choice is non-absorbable disaccharides, such as lactulose and lactitol.Probiotics are effective in the treatment of minimal hepatic encephalopathy which precipitates hepatic encephalopathy. The investigators will assess the effects of lactulose and probiotics for the prevention of recurrence of HE (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic encephalopathy.

Clinical Trial Conditions for Lactitol

Condition Name

Condition Name for Lactitol
Intervention	Trials
Hepatic Encephalopathy	5
Hyponatremia	1
Renal Failure	1
Sepsis	1

Condition MeSH

Condition MeSH for Lactitol
Intervention	Trials
Hepatic Encephalopathy	5
Brain Diseases	5
Acute-On-Chronic Liver Failure	1
Gastrointestinal Hemorrhage	1

Clinical Trial Locations for Lactitol

Trials by Country

Trials by Country for Lactitol
Location	Trials
India	4
Spain	2
Egypt	1

Clinical Trial Progress for Lactitol

Clinical Trial Phase

Clinical Trial Phase for Lactitol
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Lactitol
Clinical Trial Phase	Trials
Unknown status	2
Completed	2
Recruiting	1

Clinical Trial Sponsors for Lactitol

Sponsor Name

Sponsor Name for Lactitol
Sponsor	Trials
Al-Azhar University	1
Hospital Universitari de Bellvitge	1
Maternal-Infantil Vall d´Hebron Hospital	1

Sponsor Type

Sponsor Type for Lactitol
Sponsor	Trials
Other	8

Lactitol: Clinical Trials, Market Analysis, and Projections

Introduction to Lactitol

Lactitol, a disaccharide derived from lactose, has been widely studied and used for its therapeutic and food additive properties. It is particularly notable for its use in treating constipation and hepatic encephalopathy. Here, we will delve into the current state of clinical trials, market analysis, and future projections for lactitol.

Clinical Trials and Safety Profile

Chronic Constipation Treatment

A significant clinical trial conducted by Braintree Laboratories, Inc. (BLI400-303) aimed to evaluate the safety of chronic use of lactitol monohydrate in constipated adults. This open-label, multi-center study involved approximately 300 subjects, including elderly patients, who received 21 grams of lactitol monohydrate daily for 12 months. The primary endpoints included safety assessments through adverse event monitoring, ECG data, and comparisons of chemistry, hematology, and urinalysis values. The study indicated that lactitol is a safe and effective treatment for chronic idiopathic constipation, with a favorable side-effect profile compared to other laxatives like lactulose[1].

Hepatic Encephalopathy Treatment

In the treatment of chronic hepatic encephalopathy, lactitol has been compared to other disaccharides in several randomized clinical trials. A meta-analysis showed that lactitol is as effective as lactulose in managing encephalopathy, with a pooled odds ratio of 0.83. Additionally, patients treated with lactitol experienced fewer side effects, although the difference was not statistically significant. Lactitol was also found to be more palatable than lactulose[3].

Market Analysis

Current Market Size and Growth

The global lactitol market has been growing steadily. As of 2023, the market was valued at USD 643.24 million and is expected to reach USD 672.64 million in 2024. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.65%, reaching USD 884.29 million by 2030[5].

Market Dynamics and Trends

The lactitol market is influenced by several key factors, including:

• Demand from Emerging Markets: Growing demand from emerging markets and millennials is driving the market forward.
• Technological Advances: Improvements in production efficiency, product portfolio expansion, and sophisticated packaging are key growth drivers.
• Regulatory Compliance: Compliance with stringent food safety and labeling regulations is crucial but also poses challenges.
• Supply Chain Disruptions: Fluctuations in raw material prices and supply chain disruptions are significant restraints[2][5].

Geographical Insights

The market is analyzed across five major geographical regions, with detailed insights into key countries such as China, India, Japan, Australia, and Indonesia. Each region presents unique growth opportunities and challenges, necessitating tailored strategies for market players[2].

Market Projections

Future Growth Potential

The lactitol market is expected to grow healthily over the next eight years, driven by increasing demand and technological advancements. Here are some key projections:

• Revenue Growth: The market is forecasted to grow at a CAGR of 4.65% from 2023 to 2030.
• Regional Opportunities: Asia-Pacific, particularly countries like China and India, are expected to show significant growth due to rising consumer demand and economic development.
• Product and Application Trends: The most profitable products and dominant end-users will continue to evolve, with a focus on food additives, pharmaceuticals, and other applications[2][5].

Challenges and Opportunities

Challenges

• Supply Chain Disruptions: Fluctuations in raw material prices and supply chain issues can impact production and distribution.
• Regulatory Compliance: Adhering to stringent regulations on food safety and labeling is a significant challenge.
• Competition: Growing competition in the market necessitates innovative strategies to maintain market share[2].

Opportunities

• Emerging Markets: Expanding into emerging markets offers significant growth potential.
• Technological Innovations: Advances in production and packaging can enhance product appeal and efficiency.
• Diversification: Exploring new applications and distribution channels can further boost market growth[2][5].

Key Takeaways

• Clinical Safety and Efficacy: Lactitol has been proven safe and effective in treating chronic constipation and hepatic encephalopathy.
• Market Growth: The global lactitol market is projected to grow at a CAGR of 4.65% from 2023 to 2030.
• Regional Focus: Asia-Pacific regions, especially China and India, are expected to drive significant growth.
• Challenges and Opportunities: Market players must navigate supply chain disruptions, regulatory compliance, and growing competition while leveraging technological innovations and emerging market opportunities.

FAQs

What is lactitol used for?

Lactitol is primarily used for treating chronic constipation and hepatic encephalopathy. It is also used as a food additive due to its prebiotic properties.

How safe is lactitol for long-term use?

Clinical trials have shown that lactitol is safe for long-term use, with a favorable side-effect profile compared to other laxatives like lactulose[1][3].

What are the key growth drivers for the lactitol market?

Key growth drivers include increasing demand from emerging markets, technological advancements in production and packaging, and the expanding product portfolio[2][5].

What are the main challenges facing the lactitol market?

The main challenges include supply chain disruptions, compliance with stringent regulations, growing competition, and fluctuating raw material prices[2].

Which regions are expected to drive the growth of the lactitol market?

The Asia-Pacific region, particularly countries like China and India, are expected to drive significant growth in the lactitol market[2].

Sources

1. Braintree Laboratories, Inc. - NCT02819310 STUDY PROTOCOL An Open Label Study of BLI400 (Lactitol Monohydrate NF Powder for Reconstitution) as a Treatment for Adult Constipation.
2. Research and Markets - Lactitol Market Outlook Report: Industry Size, Competition, Trends, and Growth Opportunities.
3. PubMed - Lactitol in treatment of chronic hepatic encephalopathy. A meta-analysis of randomized clinical trials.
4. FDA - PIZENSY (Lactitol) Label.
5. GII Research - Lactitol Market by Product Type, Functionality, and End-User.